Amoxicillin and Clavulanate Potassium

Do not take it if

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 or 875 mg every 12 hours or 250 mg or 500 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.
• ( 2.3 )
• 2.1 Important Administration Instructions Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are administered at the start of a meal.
• To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be taken at the start of a meal.
• 2.2 Adult Patients See dosing regimens of amoxicillin/clavulanate potassium (based on the amoxicillin component) provided in Table 1 below.
• Table 1.
• Dosing Regimens of Amoxicillin/Clavulanate Potassium in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF AMOXICILLIN/CLAVULANATE POTASSIUM Severe infections and infections of the respiratory tract one 875 mg tablet a of amoxicillin/clavulanate potassium every 12 hours or one 500 mg tablet b,c of amoxicillin/clavulanate potassium every 8 hours Less severe infections one 500 mg tablet b,c of amoxicillin/clavulanate potassium every 12 hours or one 250 mg tablet d of amoxicillin/clavulanate potassium 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 for oral suspension or the amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral 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 for oral suspension or amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL for oral 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 for oral suspension should be dosed as follows:
• Neonates and Infants Aged less than 12 Weeks (less than 3 Months) :
• See dosing regimens of amoxicillin/clavulanate potassium provided in Table 2 below.
• Table 2:
• Dosing Regimens of Amoxicillin and Clavulanate Potassium for Oral Suspension 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 for oral suspension 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 )] .
• The amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral suspension and amoxicillin and clavulanate potassium 200 mg/28.5 mg and amoxicillin and clavulanate tablets (chewable) 400 mg/57 mg contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions ( 5.8 )] .
• Table 3:
• Dosing in Patients Aged 12 Weeks (3 Months) and Older and Weighing Less than 40 kg INFECTION DOSING REGIMEN Every 12 hours Amoxicillin/Clavulanate Potassium 200 mg/28.5 mg per 5 mL for Oral Suspension or Amoxicillin/Clavulanate Potassium 400 mg/57 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 Less severe infections 25 mg/kg/day every 12 hours Each strength of amoxicillin and clavulanate potassium for oral suspension is available as a chewable tablet for use by older children.
• 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 tablets 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 tablets versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium tablets (chewable).
• 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 tablets.
• 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
• 2.5 Directions for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension Prepare amoxicillin and clavulanate potassium for oral suspension at time of dispensing as follows:
• Tap bottle until all powder flows freely.
• Measure a total (see Table 5 below for total amount of water for reconstitution) OF WATER.
• Add approximately 2/3 of the water to the powder.
• Replace cap and shake VIGOROUSLY.
• Add remaining water.
• Replace cap and shake VIGOROUSLY.
• Table 5:
• Amount of Water for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension Strength of Amoxicillin and Clavulanate Potassium for Oral Suspension Bottle Size Amount of Water for Reconstitution Contents of Each Teaspoonful (5 mL) 200 mg/28.5 mg per 5 mL 100 mL 92 mL 200 mg of amoxicillin and 28.5 mg of clavulanic acid as the potassium salt 400 mg/57 mg per 5 mL 100 mL 87 mL 400 mg of amoxicillin and 57 mg of clavulanic acid as the potassium salt Shake oral suspension well before using.
• Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
• Some color change is normal during dosing period.
• 2.6 Switching between Dosage Forms and between Strengths Amoxicillin and Clavulanate Potassium Tablet, 250 mg/125 mg are NOT Substitutable with Amoxicillin and Clavulanate Potassium Chewable Tablet, 250 mg/62.5 mg The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium tablets and the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium tablets (chewable) should NOT be substituted for each other and the tablet of 250 mg/125 mg amoxicillin and clavulanate potassium tablets should NOT be used in pediatric patients weighing less than 40 kg [see Dosage and Administration ( 2.3 )] .
• The 250 mg tablet of amoxicillin and clavulanate potassium tablets and the tablet of 250 mg amoxicillin and clavulanate potassium tablets (chewable) do not contain the same amount of clavulanic acid.
• The 250 mg tablet of amoxicillin and clavulanate potassium tablets contain 125 mg of clavulanic acid whereas the 250 mg tablet of amoxicillin and clavulanate potassium tablets (chewable) contain 62.5 mg of clavulanic acid.
• Two Amoxicillin and Clavulanate Potassium Tablets, 250 mg/125 mg are NOT Substitutable with One Amoxicillin and Clavulanate Potassium Tablet, 500 mg/125 mg Two 250 mg/125 mg amoxicillin and clavulanate potassium tablets should NOT be substituted for one 500 mg/125 mg amoxicillin and clavulanate potassium tablet.
• Since both the 250 mg and 500 mg tablets of amoxicillin and clavulanate potassium tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of amoxicillin and clavulanate potassium tablets are not equivalent to one 500 mg tablet of amoxicillin and clavulanate potassium tablet.

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

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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

Other medicines

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.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) have been established in pediatric patients.
• Use of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) 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 for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) 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/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 Teva at 1-888-838-2872 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/clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin/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/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/clavulanate potassium.
• Gastrointestinal:
• Indigestion, gastritis, stomatitis, glossitis, Drug-induced enterocolitis syndrome (DIES), 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/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/clavulanate potassium.
• There have been reports of increased prothrombin time in patients receiving amoxicillin/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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) contain 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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable), should only be used to treat bacterial infections.
• They do not treat viral infections (e.g., the common cold).
• When amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are 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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) or other antibacterial drugs in the future.
• Storage Instructions Advise patients to keep suspension refrigerated.
• Shake well before using.
• When dosing a child with the suspension (liquid) of amoxicillin/clavulanate potassium, use a calibrated oral syringe.
• Be sure to rinse the calibrated oral syringe after each use.
• Bottles of suspension of amoxicillin/clavulanate potassium may contain more liquid than required.
• Follow your doctor’s instructions about the amount to use and the days of treatment your child requires.
• Discard any unused medicine.
• Brands listed are the trademarks of their respective owners.
• Manufactured In Canada By:
• Teva Canada Limited Toronto, Canada M1B 2K9 Manufactured For:
• Teva Pharmaceuticals Parsippany, NJ 07054 Rev.
• G 6/2024

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

Strengths and forms

• FORMS AND STRENGTHS Amoxicillin and Clavulanate Potassium Tablets, USP 500 mg/125 mg:
• White, oblong–shaped, biconvex, film–coated, unscored tablets, debossed 93 on one side and 2274 on the other side.
• Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. 875 mg/125 mg:
• White, capsule–shaped, biconvex, film–coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side.
• Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.
• Amoxicillin and Clavulanate Potassium for Oral Suspension USP 200 mg/28.5 mg per 5 mL:
• White to off–white, orange–raspberry flavored powder for oral suspension (each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt). 400 mg/57 mg per 5 mL:
• White to off–white, orange–raspberry flavored powder for oral suspension (each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt).
• Amoxicillin and Clavulanate Potassium Chewable Tablets, USP 200 mg/28.5 mg:
• Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2270 on the other. 400 mg/57 mg:
• Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2272 on the other.
• Tablets: 500 mg/125 mg tablet and a scored 875 mg/125 mg tablet.
• ( 3 ) For Oral Suspension:
• 200 mg/28.5 mg per 5 mL, and 400 mg/57 mg per 5 mL ( 3 ) Chewable Tablets:
• 200 mg/28.5 mg, and 400 mg/57 mg ( 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 are supplied as follows:
• 500 mg/125 mg:
• White, oblong–shaped, biconvex, film–coated, unscored tablets, debossed 93 on one side and 2274 on the other side.
• Each tablet contains 500 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt.
• They are available in bottles of:
• NDC 55289-845-06 Bottles of 6 NDC 55289-845-20 Bottles of 20 NDC 55289-845-21 Bottles of 21 NDC 55289-845-28 Bottles of 28 NDC 55289-845-30 Bottles of 30
• Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
• Dispense in a tight, light–resistant container as defined in the USP, with a child–resistant closure (as required).
• Keep this and all medications out of the reach of children.

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

What is in it

• Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are oral antibacterial combinations consisting of the semisynthetic antibiotic amoxicillin, USP and the beta–lactamase inhibitor, clavulanate potassium, USP (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6–aminopenicillanic acid. Chemically, amoxicillin, USP is ( 2S , 5R , 6R )–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 has the following structural formula:
• C 16 H 19 N 3 O 5 S
• 3H 2 O M.W. 419.45 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. Chemically, clavulanate potassium, USP is potassium ( Z )-(2 R ,5 R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula:
• C 8 H 8 KNO 5 M.W. 237.25 Amoxicillin and Clavulanate Potassium Tablets, USP:
• 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). Amoxicillin and Clavulanate Potassium for Oral Suspension, USP:
• 200 mg/28.5 mg per 5 mL:
• Following reconstitution, each 5 mL of oral suspension contains 200 mg of amoxicillin, USP as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium). 400 mg/28.5 mg per 5 mL:
• Following reconstitution, each 5 mL of oral suspension contains 400 mg of amoxicillin, USP as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium). Amoxicillin and Clavulanate Potassium Tablets, USP (Chewable):
• 200 mg/28.5 mg:
• Each chewable tablet contains 200 mg of amoxicillin, USP as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium). 400 mg/57 mg:
• Each chewable tablet contains 400 mg of amoxicillin, USP as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium). Inactive Ingredients:
• Amoxicillin and Clavulanate Potassium Tablets, USP - colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin. Each tablet of amoxicillin and clavulanate potassium tablets, USP contains 0.63 mEq potassium. Amoxicillin and Clavulanate Potassium for Oral Suspension, USP - artificial raspberry powder, aspartame, citric acid, colloidal silicon dioxide, mannitol, hypromellose, natural orange flavor, sodium citrate, sodium saccharin and xanthan gum [see Warnings and Precautions ( 5.8 ] . Each 5 mL of reconstituted 200 mg/28.5 mg oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassium Each 5 mL of reconstituted 400 mg/57 mg oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassium Amoxicillin and Clavulanate Potassium Tablets, USP (Chewable) - aspartame, colloidal silicon dioxide, FD&C Red #40 lake, magnesium stearate, mannitol, microcrystalline cellulose, SA84 artificial ripe banana flavor, and artificial cherry flavor powder [see Warnings and Precautions ( 5.8 ] . Each 200 mg/28.5 mg chewable tablet of amoxicillin and clavulanate potassium contains 0.14 mEq potassium Each 400 mg/57 mg chewable tablet of amoxicillin and clavulanate potassium contains 0.29 mEq potassium amoxicillin structural formula clavulanic acid structural formula

Quoted from the official label, section “Description”.

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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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