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ACID REDUCER
Famotidine · Tablet, Film Coated
Overview
Active ingredients
Source: NDC DirectoryForms, 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 |
|---|---|---|---|---|---|---|---|
| 077351-001 | FAMOTIDINE | TABLET | FAMOTIDINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 28 | Manufacturing (CMC) | Approved | August 18, 2021 | Standard |
| Supplement | 23 | Labeling | Approved | February 18, 2021 | Standard |
| Supplement | 18 | Manufacturing (CMC) | Approved | April 26, 2016 | Unknown |
| Original application | 1 | Approved | September 25, 2006 | — |
Review documents
- 0 · Original application · September 27, 2006
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260818). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • 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 foods and beverages
Purpose
openFDA Drug LabelingPurpose Acid reducer
Dosage and Administration
openFDA Drug LabelingDIRECTIONS • adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Warnings
openFDA Drug LabelingWarnings Allergy alert: Do not use if you are allergic to cimetidine or other acid reducers 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 before use if you have • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • 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 • kidney disease • liver disease Ask a doctor or pharmacist before use if you are taking • a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • you need to take this product for more than 14 days • stomach pain continues • your heartburn continues or worsens If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo 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 you have • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • 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 • kidney disease • liver disease
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • you need to take this product for more than 14 days • stomach pain continues • your heartburn continues or worsens
Active Ingredient
openFDA Drug LabelingACTIVE INGREDIENT (IN EACH TABLET) Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 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 |
|---|---|---|---|---|
| 72288-470-76 | 72288-470 | Amazon.com Services LLC | 1 BOTTLE in 1 CARTON (72288-470-76) / 120 TABLET, FILM COATED in 1 BOTTLE (72288-470-00) | July 30, 2026 |
| 72288-756-75 | 72288-756 | Amazon.com Services LLC | 1 BOTTLE in 1 CARTON (72288-756-75) / 90 TABLET, FILM COATED in 1 BOTTLE (72288-756-00) | August 27, 2026 |
| 69842-659-63 | 69842-659 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (69842-659-63) / 25 TABLET, FILM COATED in 1 BOTTLE | April 4, 2022 |
| 69842-659-71 | 69842-659 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (69842-659-71) / 50 TABLET, FILM COATED in 1 BOTTLE | April 1, 2025 |
| 51316-511-63 | 51316-511 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE in 1 CARTON (51316-511-63) / 25 TABLET, FILM COATED in 1 BOTTLE | April 13, 2026 |
| 51316-511-71 | 51316-511 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE in 1 CARTON (51316-511-71) / 50 TABLET, FILM COATED in 1 BOTTLE | April 20, 2026 |
| 51316-511-78 | 51316-511 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE in 1 CARTON (51316-511-78) / 100 TABLET, FILM COATED in 1 BOTTLE | April 22, 2026 |
| 51316-511-98 | 51316-511 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE in 1 CARTON (51316-511-98) / 75 TABLET, FILM COATED in 1 BOTTLE | June 24, 2026 |
| 51316-816-39 | 51316-816 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE in 1 CARTON (51316-816-39) / 30 TABLET, FILM COATED in 1 BOTTLE | August 3, 2026 |
| 59640-023-71 | 59640-023 | H E B | 1 BOTTLE in 1 CARTON (59640-023-71) / 50 TABLET, FILM COATED in 1 BOTTLE | December 19, 2022 |
| 42507-141-75 | 42507-141 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-141-75) / 90 TABLET, FILM COATED in 1 BOTTLE (42507-141-90) | February 25, 2026 |
| 42507-194-01 | 42507-194 | HyVee Inc | 25 BLISTER PACK in 1 CARTON (42507-194-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK | February 25, 2026 |
| 42507-194-71 | 42507-194 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE (42507-194-50) | February 25, 2026 |
| 42507-194-78 | 42507-194 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE (42507-194-00) | March 18, 2026 |
| 56062-088-02 | 56062-088 | Publix Super Markets Inc | 25 BLISTER PACK in 1 CARTON (56062-088-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK | March 6, 2026 |
| 56062-141-65 | 56062-141 | Publix Super Markets Inc | 30 BLISTER PACK in 1 CARTON (56062-141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK | November 23, 2009 |
| 67091-244-30 | 67091-244 | WinCo Foods, LLC | 1 BOTTLE in 1 CARTON (67091-244-30) / 30 TABLET, FILM COATED in 1 BOTTLE | January 8, 2015 |
| 72288-470 | 72288-470 | Amazon.com Services LLC | — | July 30, 2026 |
| 72288-756 | 72288-756 | Amazon.com Services LLC | — | August 27, 2026 |
| 69842-659 | 69842-659 | CVS Pharmacy | — | April 4, 2022 |
| 51316-511 | 51316-511 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | April 13, 2026 |
| 51316-816 | 51316-816 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | August 3, 2026 |
| 59640-023 | 59640-023 | H E B | — | December 19, 2022 |
| 42507-141 | 42507-141 | HyVee Inc | — | October 19, 2009 |
| 42507-194 | 42507-194 | HyVee Inc | — | February 25, 2026 |
| 56062-088 | 56062-088 | Publix Super Markets Inc | — | March 6, 2026 |
| 56062-141 | 56062-141 | Publix Super Markets Inc | — | November 23, 2009 |
| 67091-244 | 67091-244 | WinCo Foods, LLC | — | August 2, 2012 |
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 · 11 sections on this page.