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Famotidine 20 mg
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Famotidine | 20 mg/1 | 283641 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Histamine H2 Receptor Antagonists [MoA] | MoA | All 48 members |
| Histamine-2 Receptor Antagonist [EPC] | EPC | All 48 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 217543-001 | FAMOTIDINE | TABLET | FAMOTIDINE | Over-the-counter | — | ||
| 217543-002 | FAMOTIDINE | TABLET | FAMOTIDINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | March 8, 2023 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250506). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUSE(S) Uses •relieves heartburn associated with acid indigestion and sour stomach •prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Purpose
openFDA Drug LabelingPURPOSE Purpose Acid reducer
Dosage and Administration
openFDA Drug LabelingDirections For 10 mg: • adults and children 12 years and over: o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. o to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn o do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor For 20 mg: • adults and children 12 years and over: o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. o to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn o do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor
Warnings
openFDA Drug LabelingWARNINGS Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do Not Use
openFDA Drug LabelingDO NOT USE Do not use •if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. •with other acid reducers
Ask a Doctor
openFDA Drug LabelingASK A DOCTOR BEFORE USE IF Ask a doctor before use if you have •had heartburn over 3 months. This may be a sign of a more serious condition. •heartburn with lightheadedness, sweating, or dizziness •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness •frequent chest pain •frequent wheezing, particularly with heartburn •unexplained weight loss •nausea or vomiting •stomach pain •kidney disease
Stop Use
openFDA Drug LabelingSTOP USE AND ASK DOCTOR IF Stop use and ask a doctor if •your heartburn continues or worsens •you need to take this product for more than 14 days
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet) For 10 mg: Famotidine USP 10 mg For 20 mg: Famotidine USP 20 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: FAMOTIDINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 25000-087-03 | 25000-087 | MARKSANS PHARMA LIMITED | 1 BOTTLE in 1 CARTON (25000-087-03) / 30 TABLET, COATED in 1 BOTTLE | March 10, 2023 |
| 25000-087-05 | 25000-087 | MARKSANS PHARMA LIMITED | 1 BOTTLE in 1 CARTON (25000-087-05) / 50 TABLET, COATED in 1 BOTTLE | April 24, 2024 |
| 25000-087-08 | 25000-087 | MARKSANS PHARMA LIMITED | 1 BOTTLE in 1 CARTON (25000-087-08) / 100 TABLET, COATED in 1 BOTTLE | March 10, 2023 |
| 25000-087-36 | 25000-087 | MARKSANS PHARMA LIMITED | 3 BLISTER PACK in 1 CARTON (25000-087-36) / 10 TABLET, COATED in 1 BLISTER PACK | March 10, 2023 |
| 25000-087-82 | 25000-087 | MARKSANS PHARMA LIMITED | 1 BOTTLE in 1 CARTON (25000-087-82) / 200 TABLET, COATED in 1 BOTTLE | February 15, 2024 |
| 25000-124-68 | 25000-124 | MARKSANS PHARMA LIMITED | 300 TABLET, COATED in 1 BOTTLE (25000-124-68) | May 23, 2025 |
| 25000-124-84 | 25000-124 | MARKSANS PHARMA LIMITED | 1 BOTTLE in 1 CARTON (25000-124-84) / 25 TABLET, COATED in 1 BOTTLE | May 23, 2025 |
| 25000-124-94 | 25000-124 | MARKSANS PHARMA LIMITED | 5 BLISTER PACK in 1 CARTON (25000-124-94) / 5 TABLET, COATED in 1 BLISTER PACK | May 23, 2025 |
| 25000-087 | 25000-087 | MARKSANS PHARMA LIMITED | — | March 10, 2023 |
| 25000-124 | 25000-124 | MARKSANS PHARMA LIMITED | — | May 23, 2025 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.