Mediclarum
Medicine guide

Famotidine

40 mg/5mL · Powder, for Suspension

  • Prescription only
  • Histamine-2 Receptor Antagonist
Active substance
Famotidine
Made by
Amneal Pharmaceuticals NY 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 · 2024-02-13

What it is

Histamine-2 Receptor Antagonist

Used for
  • Famotidine for oral suspension is indicated in
The label’s usual adult dose

Peptic Ulcer Disease 1 year to less than 17 years Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily; may increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily;

Active DU 40 mg once daily; or 20 mg twice daily Active GU 40 mg once daily Symptomatic Nonerosive GERD 20 mg twice daily Erosive Esophagitis due to GERD 20 mg twice daily; or 40 mg twice daily Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily Recommended pediatric dosage by indication (2.2) :

Full directions ↓
Do not take it if

Famotidine for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists.

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
259other products contain Famotidine — 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 for the treatment of:

  • Famotidine for oral suspension is indicated in
  • active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.
  • Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of:
  • peptic ulcer disease.
  • GERD with or without esophagitis and ulcerations.
  • Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:
  • GERD.
  • Famotidine for oral suspension is a histamine-2 (H 2 ) receptor antagonist indicated (1) :
  • In
  • active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of DU recurrence.
  • In pediatric patients 1 year of age and older for the treatment of:
  • peptic ulcer GERD with or without esophagitis and ulcerations In pediatric patients from birth to less than 1 year of age for the treatment of:
  • GERD.

From the official label · 2024-02-13 · DailyMed

How it works

From this product’s own US prescribing label.

Famotidine is a competitive inhibitor of histamine-2 (H 2 ) receptors.

The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion.

Half-life2.5–3.5 h
Mostly cleared after≈ 15 hfive half-lives — our arithmetic
How it leaves the body

Famotidine is eliminated by renal (65% to 70%) and metabolic (30% to 35%) routes.

With food

Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-02-13

Do not take it if

  • Famotidine for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists.
  • History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 receptor antagonists.
  • (4)

Quoted from the official label, section “Contraindications”.

How to take it

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

  • Recommended adult dosage by indication (2.1) :
  • Active DU 40 mg once daily; or 20 mg twice daily Active GU 40 mg once daily Symptomatic Nonerosive GERD 20 mg twice daily Erosive Esophagitis due to GERD 20 mg twice daily; or 40 mg twice daily Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily Recommended pediatric dosage by indication (2.2) :
  • Peptic Ulcer Disease 1 year to less than 17 years Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily; may increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily;
  • Maximum of 40 mg per day GERD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily; may increase to 1 mg/kg once daily 3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily; may increase to 1 mg/kg twice daily;
  • Maximum of 40 mg per day GERD with or without esophagitis and ulcerations 1 year to less than 17 years 0.5 mg/kg twice daily Maximum of 40 mg twice daily See full prescribing information for complete dosing information in
  • adults and pediatrics, recommended treatment duration by indication, and dosage adjustment for adult patients with renal impairment.
  • (2.1 , 2.2 , 2.3) Administration (2.3) :
  • Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.
  • Recommended Dosage in
  • Adults The recommended dosage and duration of famotidine for oral suspension in
  • adults with normal renal function is shown in Table 1.
  • Table 1:
  • Recommended Dosage and Duration of Famotidine for Oral Suspension a in
  • Adults with Normal Renal Function Indication Recommended Dosage Recommended Duration Active DU 40 mg once daily; or 20 mg twice daily b Up to 8 weeks c,d Active GU 40 mg once daily Up to 8 weeks d Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeks d Erosive esophagitis due to GERD, diagnosed by endoscopy 20 mg twice daily; or 40 mg twice daily b Up to 12 weeks Pathological hypersecretory conditions Starting dosage:
  • 20 mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160 mg every 6 hours As clinically indicated Reduction of the risk of DU recurrence 20 mg once daily 1 year c,d or as clinically indicated a After preparation, the concentration of famotidine oral suspension is 8 mg/mL [see Dosage and Administration (2.3) ] . b Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14) ] . c In clinical trials, the majority of patients healed within 4 weeks.
  • For patients who do not heal after 4 weeks, consider an additional 2 to 4 weeks of treatment [see Clinical Studies (14.1) ] . d Longer treatment durations have not been studied in clinical trials [see Clinical Studies (14.1 , 14.2 , 14.3) ] .
  • 2.2 Recommended Dosage in Pediatric Patients The recommended dosage and duration of famotidine for oral suspension in pediatric patients with normal renal function is shown in Table 2.
  • Table 2:
  • Recommended Dosage and Duration of Famotidine for Oral Suspension a in Pediatric Patients with Normal Renal Function Indication Pediatric Age Range Recommended Dosage a Duration Peptic Ulcer Disease 1 year to less than 17 years Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily.
  • May increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily Maximum of 40 mg per day 8 weeks b GERD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily.
  • May increase to 1 mg/kg once daily b Up to 8 weeks b,c,d 3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily.
  • May increase to 1 mg/kg twice daily c Maximum of 40 mg per day GERD with or without esophagitis and ulcerations 1 year to less than 17 years 0.5 mg/kg twice daily Maximum of 40 mg twice daily 6 to 12 weeks b a After preparation, the concentration of famotidine oral suspension is 8 mg/mL [see Dosage and Administration (2.3) ] . b Treatment duration based on adult recommendations (see Table 1).
  • Individualize the dose and duration based upon clinical response an/or pH determinations (gastric or esophageal) and endoscopy. c Use conservative measures (e.g., thickened feedings) concurrently [see Use in Specific Populations (8.4) ] . d After 4 weeks of treatment re-evaluate the patient.
  • Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.
  • Recommended Dosage in
  • Adults with Renal Impairment Recommended dosage adjustments for
  • adults with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) by indication are shown in Table 4.
  • Use the lowest effective dosage [see Use in Specific Populations (8.6) ] .
  • A safe and effective dosage has not been established in pediatric patients with renal impairment.
  • Table 3:
  • Recommended Maximum Dosage of Famotidine for Oral Suspension in
  • Adults with Moderate and Severe Renal Impairment Indication Recommended Maximum Dosages Creatinine clearance 30 to 60 mL/minute Creatinine clearance less than 30 mL/minute Active DU 20 mg once daily; or 40 mg every other day 10 mg once daily; or 20 mg every other day Active GU 20 mg once daily; or 40 mg every other day 10 mg once daily; or 20 mg every other day Symptomatic nonerosive GERD 20 mg once daily 10 mg once daily; or 20 mg every other day Erosive esophagitis due to GERD, diagnosed by endoscopy a 20 mg once daily; or 40 mg every other day b 40 mg once daily b 10 mg once daily; or 20 mg every other day b 20 mg once daily b Pathological hypersecretory conditions
  • Avoid use b Reduction of the risk of DU recurrence 10 mg once daily; or 20 mg every other day 10 mg every other day a Dosage adjustments for renal impairment are provided for both dosing regimens (20 mg twice daily and 40 mg twice daily) which showed effectiveness for the treatment of erosive esophagitis in clinical trials [see Clinical Studies (14.4) ] . b The dosage required to treat pathological hypersecretory conditions may exceed the maximum dosage evaluated in patients with impaired renal function.
  • The risk for increased adverse reactions in renally impaired patients treated with famotidine for oral suspension for pathological hypersecretory conditions is unknown.
  • 2.4 Administration Instructions Preparation of Constituted Suspension by a Healthcare Provider Prior to Dispensing Prior to dispensing, constitute famotidine for oral suspension by slowly adding 46 mL of Purified Water to the bottle.
  • Shake vigorously for 5 to 10 seconds immediately after adding the water.
  • The constituted suspension contains 40 mg of famotidine per 5 mL, and should be a smooth, mobile, white to off-white homogeneous suspension free from lumps.
  • Administration and Storage of Constituted Suspension Shake the bottle of constituted famotidine for oral suspension vigorously for 5 to 10 seconds prior to each use.
  • Take famotidine for oral suspension once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
  • Famotidine for oral suspension may be taken with or without food [see Clinical Pharmacology (12.3) ] .
  • Famotidine for oral suspension may be given with antacids.
  • Store the constituted suspension at 25°C (77°F).
  • Protect from freezing.
  • Discard unused constituted suspension after 30 days.

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

Other warnings

  • Elderly patients and patients with renal impairment at increased risk; reduce the dosage.
  • (2.2 , 5.1 , 8.5 , 8.6 ) GI Malignancy:
  • Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy.
  • (5.2)
  • 5.1 Central Nervous System Adverse Reactions Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine.
  • Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ] .
  • Concurrent Gastric Malignancy In
  • adults, symptomatic response to therapy with famotidine for oral suspension does not preclude the presence of gastric malignancy.
  • Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine for oral suspension.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
  • In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data ) .
  • The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15% to 20%, respectively.
  • Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2,000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine.
  • While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher.
  • There are, however, no adequate or well-controlled studies in pregnant women.
  • Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
  • IN SPECIFIC POPULATIONS Geriatric Use:
  • Use the lowest effective dose for an elderly patient and monitor renal function.
  • (2.2 , 5.1 , 8.5) Renal Impairment:
  • Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage in
  • adults.
  • (2.2 , 8.6)
  • 8.1 Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
  • In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data ) .
  • The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15% to 20%, respectively.
  • Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2,000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine.
  • While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher.
  • There are, however, no adequate or well-controlled studies in pregnant women.
  • Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
  • 8.2 Lactation Risk Summary There are limited data available on the presence of famotidine in human breast milk.
  • There were no effects on the breastfed infant.
  • There are no data on famotidine effects on milk production.
  • Famotidine is present in the milk of lactating rats (see Data ) .
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for famotidine and any potential adverse effects on the breastfed child from famotidine for oral suspension or from the underlying maternal condition.
  • Data Animal Data Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose.
  • 8.4 Pediatric Use Peptic Ulcer Disease and GERD With or Without Esophagitis and Ulcerations Pediatric Patients One Year to Less than 17 Years of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients 1 year to less than 17 years of age for the treatment of peptic ulcer disease and GERD with or without esophagitis and ulcerations.
  • Use of famotidine in this age group is supported by evidence from adequate and well-controlled studies of famotidine in
  • adults with additional pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2 , 12.3) ] .
  • The safety and effectiveness of famotidine for oral suspension for the treatment of peptic ulcer disease in pediatric patients less than one year of age have not been established.
  • GERD Pediatric Patients Less Than One Year of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients from birth to less than 1 year of age for the treatment of GERD.
  • The use of famotidine this is age group is supported by evidence from adequate and well-controlled studies of famotidine in
  • adults and with supportive data in pediatric patients from birth to less than 1 year of age [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2 , 12.3) , Clinical Studies (14.7) ] .
  • Other Conditions The safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established in pediatric patients.
  • A safe and effective dosage has not been established in pediatric patients with renal impairment.
  • 8.5 Geriatric Use Of the 1,442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older.
  • In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients.
  • In post-marketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [see Warnings and Precautions (5.1) ] .
  • Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine for oral suspension may be greater in elderly patients, particularly those with impaired renal function [see Use in Specific Populations (8.6) ] .
  • In general, use the lowest effective dose of famotidine for oral suspension for an elderly patient and monitor renal function [see Dosage and Administration (2.2) ] .
  • 8.6 Renal Impairment CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [see Warnings and Precautions (5.1) ] .
  • The clearance of famotidine is reduced in
  • adults with moderate and severe renal impairment compared to
  • adults with normal renal function [see Clinical Pharmacology (12.3) ] .
  • No dosage adjustment is needed in
  • adults with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute).
  • Dosage reduction is recommended in
  • adults with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Dosage and Administration (2.3) ] .
  • Data are not available to establish a safe and effective dosage in pediatric patients with renal impairment.

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

Other medicines

  • Drugs Dependent on Gastric pH for Absorption:
  • Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy.
  • See full prescribing information for a list of interacting drugs.
  • (7.1) Tizanidine (CYP1A2) Substrate:
  • Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness;
  • avoid concomitant use, if possible.
  • (7.2)
  • 7.1 Drugs Dependent on Gastric pH for Absorption Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity, leading to loss of efficacy of the concomitant drug.
  • Concomitant administration of famotidine for oral suspension with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended.
  • See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine.
  • 7.2 Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate.
  • Avoid concomitant use with famotidine for oral suspension.
  • If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness.
  • Refer to the full prescribing information for tizanidine.

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.

  • The types of adverse reactions in overdosage of famotidine are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions (6.1) ] .
  • In the event of overdosage, treatment should be symptomatic and supportive.
  • Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.
  • Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis.
  • There is limited experience on the usefulness of hemodialysis as a treatment for famotidine overdosage.

Quoted from the official label, section “Overdosage”.

Use in children

  • Peptic Ulcer Disease and GERD With or Without Esophagitis and Ulcerations Pediatric Patients One Year to Less than 17 Years of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients 1 year to less than 17 years of age for the treatment of peptic ulcer disease and GERD with or without esophagitis and ulcerations.
  • Use of famotidine in this age group is supported by evidence from adequate and well-controlled studies of famotidine in
  • adults with additional pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2 , 12.3) ] .
  • The safety and effectiveness of famotidine for oral suspension for the treatment of peptic ulcer disease in pediatric patients less than one year of age have not been established.
  • GERD Pediatric Patients Less Than One Year of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients from birth to less than 1 year of age for the treatment of GERD.
  • The use of famotidine this is age group is supported by evidence from adequate and well-controlled studies of famotidine in
  • adults and with supportive data in pediatric patients from birth to less than 1 year of age [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2 , 12.3) , Clinical Studies (14.7) ] .
  • Other Conditions The safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established in pediatric patients.
  • A safe and effective dosage has not been established in pediatric patients with renal impairment.

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

Use in older people

  • Of the 1,442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older.
  • In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients.
  • In post-marketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [see Warnings and Precautions (5.1) ] .
  • Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine for oral suspension may be greater in elderly patients, particularly those with impaired renal function [see Use in Specific Populations (8.6) ] .
  • In general, use the lowest effective dose of famotidine for oral suspension for an elderly patient and monitor renal function [see Dosage and Administration (2.2) ] .

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

Side effects

  • The most common adverse reactions are: headache, dizziness, constipation, and diarrhea.
  • (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 safety of famotidine for oral suspension has been established based on adequate and well-controlled studies of another oral famotidine product [see Clinical Studies (14) ] .
  • The following is a summary of the adverse reactions reported in those studies.
  • Oral famotidine was studied in 7 US and international placebo- and active-controlled trials in approximately 2,500 patients [see Clinical Studies (14) ] .
  • A total of 1,442 patients were treated with famotidine, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily.
  • The population was 17 to 91 years old, fairly well distributed between sex and race; however, the predominant race was Caucasian.
  • The following adverse reactions occurred in greater than or equal to 1% of famotidine-treated patients:
  • headache, dizziness and constipation.
  • The following other adverse reactions were reported in less than 1% of patients in clinical trials:
  • Body as a Whole:
  • fever, asthenia, fatigue Cardiovascular:
  • palpitations Gastrointestinal:
  • elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic:
  • thrombocytopenia Hypersensitivity:
  • orbital edema, rash, conjunctival injection, bronchospasm Musculoskeletal:
  • musculoskeletal pain, arthralgia Nervous System/Psychiatric:
  • seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence Skin:
  • pruritus, dry skin, flushing Special Senses:
  • tinnitus, taste disorder Other:
  • impotence Pediatric Patients Less Than One Year of Age In a clinical study in 35 pediatric patients less than 1 year of age with GERD symptoms, two patients discontinued due to adverse reactions.
  • Agitation observed in 5 patients resolved when famotidine was discontinued [see Use in Specific Populations (8.4) ] .
  • 6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of famotidine.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Cardiovascular:
  • arrhythmia, AV block, prolonged QT interval Gastrointestinal:
  • cholestatic jaundice, hepatitis Hematologic:
  • agranulocytosis, pancytopenia, leukopenia Hypersensitivity:
  • anaphylaxis, angioedema, facial edema, urticaria Musculoskeletal:
  • rhabdomyolysis, muscle cramps Nervous System/Psychiatric:
  • confusion, agitation, paresthesia Respiratory:
  • interstitial pneumonia Skin:
  • toxic epidermal necrolysis/Stevens-Johnson syndrome

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

What to discuss with your doctor

  • Central Nervous System (CNS) Adverse Reactions Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see Warnings and Precautions (5.1) ] .
  • Report symptoms immediately to a healthcare provider.
  • QT Prolongation Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see Use in Specific Populations (8.6) ] .
  • Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider.
  • Administration Advise patients to take and caregivers to administer:
  • Famotidine once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
  • Advise patients and caregivers: Famotidine may be taken with or without food.
  • Famotidine may be given with antacids.
  • Manufactured by: Amneal Pharmaceuticals Pvt.
  • Ltd.
  • Ahmedabad 382220, INDIA Distributed by:
  • Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2024-00

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

Strengths and forms

  • FORMS AND STRENGTHS For Oral Suspension: 400 mg as a white to off-white granular powder.
  • When constituted as directed, famotidine for oral suspension, USP is a smooth, mobile, white to off-white homogeneous suspension with cherry-banana-peppermint flavor free from lumps, containing 40 mg of famotidine, USP per 5 mL.
  • For oral suspension: 40 mg/5 mL (3)

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

What it looks like and how it is packed

  • Famotidine for oral suspension, USP is supplied as follows:
  • NDC Strength Quantity Description 60219-­2090-4 40 mg Bottle white to off-white granular powder.
  • When constituted as directed, famotidine for oral suspension, USP is a smooth, mobile, white to off-white homogeneous suspension with a cherry-banana-peppermint flavor free from lumps, containing 40 mg of famotidine, USP per 5 mL.
  • Prior to dispensing, constitute famotidine for oral suspension, USP [see Dosage and Administration (2.3) ] Storage Store famotidine for oral suspension, USP dry powder and constituted suspension at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
  • Protect from freezing.
  • Discard unused constituted suspension after 30 days.
  • Dispense in a USP tight, light-resistant container.

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

What is in it

  • The active ingredient in famotidine for oral suspension, USP is a histamine-2 (H 2 ) receptor antagonist.
  • Famotidine, USP is propanimidamide, N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-.
  • The empirical formula of famotidine, USP is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45.
  • Its structural formula is:
  • Each 5 mL of famotidine for oral suspension, USP when prepared as directed contains 40 mg of famotidine, USP and the following inactive ingredients:
  • citric acid monohydrate, flavors (cherry, banana, and peppermint), powdered cellulose, sucrose and xanthan gum.
  • Added as preservatives are sodium benzoate 0.1%, methylparaben sodium 0.1% and propylparaben sodium 0.02%.
  • Famotidine, USP is a white to pale yellowish white crystalline compound that is freely soluble in dimethyl formamide, glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate. 1

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.

  • SugarssucroseRelevant to diabetes and dental health.

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.

Every version of this medicine (22)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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FranceNo exact match for this strength and form

Every strength and form (2)

CanadaNo exact match for this strength and form

Every strength and form (31)

NetherlandsNo exact match for this strength and form

Every strength and form (22)

Details

Made byAmneal Pharmaceuticals NY LLC
Active substanceFamotidine
Used inDigestion, stomach, diabetes and nutrition
Strength40 mg/5mL
FormPowder, for Suspension
RouteOral
Packs50 mL in 1 BOTTLE
NDC60219-2090
NDC69238-2090

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

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

Show all forms · 8 forms

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Acid Controller20 mgWithout prescriptionTablet, Film Coated Walgreen Company · FamotidineAcid Controller20 mgWithout prescriptionTablet, Film Coated Safeway · FamotidineAcid Controller10 mgWithout prescriptionTablet, Film Coated Safeway · FamotidineAcid Controller20 mgWithout prescriptionTablet, Film Coated H E B · FamotidineAcid Controller10 mgWithout prescriptionTablet, Film Coated H E B · FamotidineAcid Controller20 mgWithout prescriptionTablet, Film Coated CVS Pharmacy · Famotidine

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