Mediclarum
Medicine guide

Amoxicillin and Clavulanate Potassium

875 mg + 125 mg · Tablet, Film Coated

  • Prescription only
  • Penicillin-class Antibacterial
Made by
Coupler LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-05-04

What it is

Penicillin-class Antibacterial

Used for
  • Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in
The label’s usual adult dose

Adults and Pediatric Patients greater than 40 kg:: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours, based on amoxicillin component.

Full directions ↓
Do not take it if

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium tablets or to other beta-lactams (e.g., penicillins or cephalosporins).

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
115other products contain Amoxicillin and Clavulanate Potassium — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:

  • Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in
  • Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis .
  • Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis .
  • Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis .
  • Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species .
  • Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species , and Enterobacter species.
  • Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.
  • Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
  • When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
  • In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • Amoxicillin and clavulanate potassium tablets are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in
  • adults and pediatric patients:
  • ( 1 ) Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure infections Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.
  • ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • ( 1 )

From the official label · 2026-05-04 · DailyMed

How it works

From this product’s own US prescribing label.

Amoxicillin and clavulanate potassium is an antibacterial drug [see Microbiology (12.4) ].

Peak level after1.5 h
Half-life1.3 h
Mostly cleared after≈ 6.5 hfive half-lives — our arithmetic
PeakHalf gone6.5 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How it leaves the body

Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single 250 mg/125 mg or 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-04

Do not take it if

  • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium tablets or to other beta-lactams (e.g., penicillins or cephalosporins).
  • ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets.
  • ( 4.2 )
  • 4.1 Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
  • 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Adults and Pediatric Patients greater than 40 kg:
  • 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours, based on amoxicillin component.
  • ( 2.2 , 2.3 ) Pediatric patients aged 12 weeks (3 months) and older:
  • 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose.
  • ( 2.3 ) Neonates and infants less than 12 weeks of age:
  • 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.
  • Use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
  • ( 2.3 )
  • 2.1 Important Administration Instructions Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal.
  • To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
  • 2.2 Adult Patients See dosing regimens of amoxicillin and clavulanate potassium tablets (based on the amoxicillin component) provided in Table 1 below.
  • Table 1.
  • Dosing Regimens of Amoxicillin and Clavulanate Potassium Tablets in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS Severe infections and infections of the respiratory tract one 875 mg/125 mg tablet a of amoxicillin and clavulanate potassium tablets every 12 hours or one 500 mg/125 mg tablet b,c of amoxicillin and clavulanate potassium tablets every 8 hours Less severe infections one 500 mg/125 mg tablet b,c of amoxicillin and clavulanate potassium tablets every 12 hours or one 250 mg/125 mg tablet d of amoxicillin and clavulanate potassium tablets every 8 hours a
  • Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension or the amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. b
  • Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. c Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg amoxicillin and clavulanate potassium tablet [see Dosage and Administration (2.6) ] . d Amoxicillin and clavulanate potassium 250 mg/125 mg tablet is NOT substitutable with amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet [see Dosage and Administration (2.6) ] .
  • 2.3 Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
  • Neonates and Infants Aged less than 12 weeks (less than 3 months) :
  • See dosing regimens of amoxicillin and clavulanate potassium tablets provided in Table 2 below.
  • Table 2:
  • Dosing Regimens of Amoxicillin and Clavulanate Potassium Tablets in Neonates and Infants Aged Less than 12 Weeks (Less than 3 Months) PATIENT POPULATION DOSING REGIMEN Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension a Neonates and Infants aged less than 12 weeks (less than 3 months) 30 mg/kg/day every 12 hours a Experience with the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension is recommended.
  • Patients Aged 12 weeks (3 months) and Older and Weighing Less than 40 kg :
  • See dosing regimens provided in Table 3 below.
  • The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2) ] .
  • Table 3:
  • Dosing in Patients Aged 12 Weeks (3 Months) and Older and Weighing Less than 40 kg INFECTION DOSING REGIMEN Every 12 hours Every 8 hours Amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL or Amoxicillin and clavulanate potassium tablets 400 mg/57 mg per 5 mL for oral suspension a Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or Amoxicillin and clavulanate potassium tablets 250 mg/62.5 mg per 5 mL for oral suspension a Otitis media b , sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours a Each strength of amoxicillin and clavulanate potassium for oral suspension is available as a chewable tablet for use by older children. b Duration of therapy studied and recommended for acute otitis media is 10 days.
  • Patients Weighing 40 kg or More :
  • Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
  • The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should NOT be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium.
  • 2.4 Patients with Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  • Renal impairment patients with a glomerular filtration rate (GFR) of less than 30 mL/min should NOT receive the 875 mg dose (based on the amoxicillin component) of amoxicillin and clavulanate potassium tablet.
  • See dosing regimens in patients with severe renal impairment provided in Table 4.
  • Table 4.
  • Dosing Regimens of Amoxicillin and Clavulanate Potassium Tablets in Patients with Severe Renal Impairment Patients with Renal Impairment Dosing Regimen GFR 10 mL/min to 30 mL/min 500 mg or 250 mg every 12 hours, depending on the severity of the infection GFR less than 10 mL/min 500 mg or 250 mg every 24 hours, depending on severity of the infection Hemodialysis 500 mg or 250 mg every 24 hours, depending on severity of the infection Administer an additional dose both during and at the end of dialysis
  • 2.6 Switching between Dosage Forms and between Strengths A moxicillin and Clavulanate Potassium 250 mg/125 mg Tablet is NOT Substitutable with Amoxicillin and Clavulanate Potassium 250 mg/62.5 mg Chewable Tablet The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium should NOT be substituted for each other and the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should NOT be used in pediatric patients weighing less than 40 kg [see Dosage and Administration (2.3) ] .
  • The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium do not contain the same amount of clavulanic acid.
  • The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid whereas the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium contains 62.5 mg of clavulanic acid.
  • Two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets are NOT Substitutable with One 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium should NOT be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.
  • Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Serious (including fatal) hypersensitivity reactions:
  • Discontinue amoxicillin and clavulanate potassium if a reaction occurs.
  • ( 5.1 ) Severe Cutaneous Adverse Reactions (SCAR): Monitor closely.
  • Discontinue if rash progresses.
  • ( 5.2 ) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets.
  • If this occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy.
  • ( 5.3 ) Hepatic dysfunction and cholestatic jaundice:
  • Discontinue if signs/symptoms of hepatitis occur.
  • Monitor liver function tests in patients with hepatic impairment.
  • Evaluate patients if diarrhea occurs.
  • ( 5.5 ) Patients with mononucleosis who receive amoxicillin and clavulanate potassium develop skin rash.
  • Avoid amoxicillin and clavulanate potassium use in these patients.
  • ( 5.6 ) Overgrowth:
  • The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.
  • ( 5.7 )
  • 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin and clavulanate potassium.
  • These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
  • Before initiating therapy with amoxicillin and clavulanate potassium, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
  • If an allergic reaction occurs, amoxicillin and clavulanate potassium should be discontinued, and appropriate therapy instituted.
  • 5.2 Severe Cutaneous Adverse Reactions Amoxicillin and clavulanate potassium may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
  • If patients develop a skin rash, they should be monitored closely, and amoxicillin and clavulanate potassium discontinued if lesions progress.
  • 5.3 Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets [see Adverse Reactions (6.2) ] , with most cases occurring in pediatric patients ≤ 18 years of age.
  • DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms.
  • DIES maybeassociated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours of ingesting amoxicillin, and leukocytosis with neutrophilia.
  • If DIES occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy.
  • 5.4 Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin and clavulanate potassium.
  • Hepatic toxicity is usually reversible; however, deaths have been reported.
  • Hepatic function should be monitored at regular intervals in patients with hepatic impairment.
  • 5.5 Clostridioides difficile Associated Diarrhea (CDAD) Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium, and may range in severity from mild diarrhea to fatal colitis.
  • Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
  • C. difficile produces toxins A and B which contribute to the development of CDAD.
  • Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
  • CDAD must be considered in all patients who present with diarrhea following antibacterial use.
  • Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
  • If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
  • Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
  • 5.6 Skin Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash.
  • Thus, amoxicillin and clavulanate potassium should not be administered to patients with mononucleosis.
  • 5.7 Potential for Microbial Overgrowth The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.
  • If superinfection occurs, amoxicillin and clavulanate potassium should be discontinued and appropriate therapy instituted.
  • 5.9 Development of Drug-Resistant Bacteria Prescribing amoxicillin and clavulanate potassium in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Teratogenic Effects: Pregnancy Category B.
  • Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium.
  • The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours).
  • For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours).
  • There are, however, no adequate and well-controlled studies in pregnant women.
  • Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
  • Amoxicillin has been shown to be excreted in human milk.
  • Amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants.
  • Caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.
  • IN SPECIFIC POPULATIONS Pediatric Use: Modify dose in patients 12 weeks or younger.
  • (8.4) Renal Impairment:
  • Dosage adjustment is recommended for severe renal impairment (GFR less than 30 mL/min).
  • (2.4, 8.6)
  • 8.1 Pregnancy Teratogenic Effects: Pregnancy Category B.
  • Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium.
  • The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours).
  • For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours).
  • There are, however, no adequate and well-controlled studies in pregnant women.
  • Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
  • 8.2 Labor and Delivery Oral ampicillin-class antibacterials are poorly absorbed during labor.
  • It is not known whether use of amoxicillin and clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.
  • 8.3 Nursing Mothers Amoxicillin has been shown to be excreted in human milk.
  • Amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants.
  • Caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.
  • 8.4 Pediatric Use The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients.
  • Use of amoxicillin and clavulanate potassium tablets in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in
  • adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see Clinical Studies (14.2) ] .
  • Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group.
  • Dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see Dosage and Administration (2.3) ] .
  • 8.5 Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old.
  • No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
  • This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
  • 8.6 Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min).
  • See Patients with Renal Impairment [see Dosage and Administration (2.4) ] for specific recommendations in patients with renal impairment.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Co-administration with probenecid is not recommended.
  • (7.1) Concomitant use of amoxicillin and clavulanate potassium and oral anticoagulants may increase the prolongation of prothrombin time.
  • (7.2) Co-administration with allopurinol increases the risk of rash.
  • (7.3) Amoxicillin and clavulanate potassium may reduce efficacy of oral contraceptives.
  • (7.4)
  • 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid.
  • Concurrent use with amoxicillin and clavulanate potassium may result in increased and prolonged blood concentrations of amoxicillin.
  • Co-administration of probenecid is not recommended.
  • 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants.
  • Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with amoxicillin and clavulanate potassium.
  • Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
  • 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone.
  • It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
  • 7.4 Oral Contraceptives Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
  • 7.5 Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution.
  • Since this effect may also occur with amoxicillin and clavulanate potassium, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
  • Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required.
  • A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms 1 .
  • Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium.
  • Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and clavulanate potassium overdosage in adult and pediatric patients.
  • In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin and clavulanate potassium crystalluria.
  • Renal impairment appears to be reversible with cessation of drug administration.
  • High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin and clavulanate potassium.
  • Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration (2.4) ] .

Quoted from the official label, section “Overdosage”.

Use in children

  • The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients.
  • Use of amoxicillin and clavulanate potassium tablets in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in
  • adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see Clinical Studies (14.2) ] .
  • Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group.
  • Dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see Dosage and Administration (2.3) ] .

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old.
  • No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
  • This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The following are discussed in more detail in other sections of the labeling:
  • Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3) ] Hepatic Dysfunction [see Warnings and Precautions (5.4) ] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.5) ] The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).
  • (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
  • 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).
  • Less than 3% of patients discontinued therapy because of drug-related adverse reactions.
  • The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose.
  • Other less frequently reported adverse reactions (less than 1%) include:
  • Abdominal discomfort, flatulence, and headache.
  • In pediatric patients (aged 2 months to 12 years), 1 U.S./Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media.
  • A total of 575 patients were enrolled, and only the suspension formulations were used in this trial.
  • Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes [see Clinical Studies (14.2) ] .
  • 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of amoxicillin and clavulanate potassium.
  • Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
  • These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin and clavulanate potassium.
  • Gastrointestinal:
  • Drug-induced enterocolitis syndrome (DIES), indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis.
  • Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.5) ] .
  • Immune:
  • Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1 )].
  • Skin and Appendages:
  • Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis.
  • Liver:
  • Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium.
  • It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.
  • The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes.
  • The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued.
  • The hepatic dysfunction, which may be severe, is usually reversible.
  • Deaths have been reported [see Contraindications (4.2) , Warnings and Precautions (5.4) ] .
  • Renal:
  • Interstitial nephritis, hematuria, and crystalluria have been reported [see Overdosage (10) ] .
  • Hemic and Lymphatic Systems:
  • Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported.
  • These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
  • Thrombocytosis was noted in less than 1% of the patients treated with amoxicillin and clavulanate potassium.
  • There have been reports of increased prothrombin time in patients receiving amoxicillin and clavulanate potassium and anticoagulant therapy concomitantly [see Drug Interactions (7.2) ] .
  • Central Nervous System:
  • Agitation, anxiety, behavioral changes, aseptic meningitis, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.
  • Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported.
  • Most reports occurred in pediatric patients.
  • Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Administration Instructions Inform patients that amoxicillin and clavulanate potassium tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed.
  • Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset.
  • Allergic Reactions Counsel patients that amoxicillin and clavulanate potassium tablets contains a penicillin class drug product that can cause allergic reactions in some individuals.
  • Severe Cutaneous Adverse Reactions (SCAR ) Advise patients about the signs and symptoms of serious skin manifestations.
  • Instruct patients to stop taking amoxicillin and clavulanate potassium tablets immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions (5.2) ] .
  • Diarrhea Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued.
  • Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial.
  • If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician as soon as possible.
  • Antibacterial Resistance Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium tablets, should only be used to treat bacterial infections.
  • They do not treat viral infections (e.g., the common cold).
  • When amoxicillin and clavulanate potassium tablet is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
  • Skipping doses or not completing the full course of therapy may:
  • (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium tablets or other antibacterial drugs in the future.
  • CLINITEST is a registered trademark of Miles, Inc.
  • Distributed by:
  • Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by:
  • Aurobindo Pharma Limited Hyderabad-500 032, India Revised:
  • 06/2024

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS 250 mg/125 mg :
  • White to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side, contains 250 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt. 500 mg/125 mg:
  • White to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side, contains 500 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt. 875 mg/125 mg:
  • White to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side, contains 875 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt.
  • Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored.
  • ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Amoxicillin and Clavulanate Potassium Tablets USP, 250 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side, contains 250 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium).
  • Bottles of 30 NDC 65862-501-30 Bottles of 500 NDC 65862-501-05 Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side, contains 500 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium).
  • Bottles of 20 NDC 65862-502-20 Bottles of 500 NDC 65862-502-05 Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side, contains 875 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium).
  • Bottles of 20 NDC 65862-503-20 Bottles of 100 NDC 65862-503-01 Dispense in a tight container [see USP].
  • Advise patients to keep in a closed container.
  • Use only if inner seal is intact.
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Keep out of the reach of children.

Quoted from the official label, section “How Supplied”.

What is in it

  • Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S
  • 3H 2 O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S, 5 R, 6 R )-6-[( R )-(-)-2-Amino-2-( p- hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:
  • Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8 H 8 KNO 5 , and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z )( 2R,5R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:
  • 250 mg/125 mg:
  • Each tablet contains 250 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).
  • 500 mg/125 mg:
  • Each tablet contains 500 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).
  • 875 mg/125 mg:
  • Each tablet contains 875 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). Inactive Ingredients:
  • Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide. Each tablet of amoxicillin and clavulanate contains 0.63 mEq potassium.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made byCoupler LLC
Active substanceAmoxicillin and Clavulanate Potassium
Used inAntibiotics, antivirals and antifungals taken into the body
Strength875 mg + 125 mg
FormTablet, Film Coated
RouteOral
Packs30 TABLET, FILM COATED in 1 BLISTER PACK
NDC67046-0955

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

114 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

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Same active substance

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Amoxicillin and Clavulanate Potassium500 mg + 125 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals USA, Inc. · Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium875 mg + 125 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals USA, Inc. · Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium200 mg/5mL + 28.5 mg/5mLPrescription onlyPowder, for Suspension Teva Pharmaceuticals USA, Inc. · Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium400 mg/5mL + 57 mg/5mLPrescription onlyPowder, for Suspension Teva Pharmaceuticals USA, Inc. · Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium600 mg/5mL + 42.9 mg/5mLPrescription onlyPowder, for Suspension Teva Pharmaceuticals USA, Inc. · Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium875 mg + 125 mgPrescription onlyTablet Hikma Pharmaceuticals USA Inc. · Amoxicillin and Clavulanate Potassium

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