heartburn prevention — Tablet, Film Coated

Overview

Brand name

heartburn prevention

Generic name

Famotidine

Dosage form

Tablet, Film Coated

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Kroger Company

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

3

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Cimetidine	200 mg/1	197505	View
Famotidine	20 mg/1	283641	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated

Route of administration

Oral

Presentations

5

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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@FDA NDC Directory

Application number

077351

Application type

ANDA · Abbreviated New Drug Application

Approval date

September 25, 2006

Sponsor

PERRIGO R AND D

Products on application

1

Submissions recorded

4

Products approved under application 077351.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
077351-001	FAMOTIDINE	TABLET		FAMOTIDINE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 077351.
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 Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260811). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260811 HUMAN OTC DRUG · 20250826

Indications and Usage

openFDA Drug Labeling

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 foods and beverages

Purpose

openFDA Drug Labeling

Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions • adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. • 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 • do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor

Warnings

openFDA Drug Labeling

Warnings 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 Labeling

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 Labeling

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

Stop Use

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Cimetidine 200 mg

Adverse event reports

Source: openFDA FAERS

118,947

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
59640-022-72	59640-022	H E B	1 BOTTLE in 1 CARTON (59640-022-72) / 60 TABLET, FILM COATED in 1 BOTTLE	November 4, 2022
30142-194-71	30142-194	Kroger Company	1 BOTTLE in 1 CARTON (30142-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE	February 5, 2015
30142-194-98	30142-194	Kroger Company	1 BOTTLE in 1 CARTON (30142-194-98) / 75 TABLET, FILM COATED in 1 BOTTLE	April 14, 2025
59640-022	59640-022	H E B	—	November 4, 2022
30142-194	30142-194	Kroger Company	—	February 5, 2015

Sources for this page

Every dataset that contributed a fact to 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.