Maximum Strength Acid Reducer — Tablet

Overview

Brand name

Maximum Strength Acid Reducer

Generic name

Famotidine

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

TARGET CORPORATION

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

6

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
Famotidine	20 mg/1	283641	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

8

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

217543

Application type

ANDA · Abbreviated New Drug Application

Approval date

March 8, 2023

Sponsor

MARKSANS PHARMA

Products on application

2

Submissions recorded

1

Products approved under application 217543.
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

Most recent submissions on application 217543.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	March 8, 2023	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240513). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240513 HUMAN OTC DRUG · 20240306

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 food 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 famotidine 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 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 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 your heartburn continues or worsens you need to take this product for more than 14 days 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 (1-800-222-1222) right away.

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 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

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop Use

openFDA Drug Labeling

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 Labeling

Active ingredient (in each tablet) Famotidine USP 20 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
11673-697-01	11673-697	TARGET CORPORATION	2 BOTTLE in 1 CARTON (11673-697-01) / 50 TABLET in 1 BOTTLE	May 15, 2024
11673-697-05	11673-697	TARGET CORPORATION	1 BOTTLE in 1 CARTON (11673-697-05) / 50 TABLET in 1 BOTTLE	May 15, 2024
11673-697-20	11673-697	TARGET CORPORATION	1 BOTTLE in 1 CARTON (11673-697-20) / 200 TABLET in 1 BOTTLE	May 15, 2024
11673-697-52	11673-697	TARGET CORPORATION	5 BLISTER PACK in 1 CARTON (11673-697-52) / 5 TABLET in 1 BLISTER PACK	May 15, 2024
49483-720-01	49483-720	TIME CAP LABORATORIES,INC	100 TABLET in 1 BOTTLE (49483-720-01)	March 11, 2024
49483-720-20	49483-720	TIME CAP LABORATORIES,INC	200 TABLET in 1 BOTTLE (49483-720-20)	June 15, 2023
11673-697	11673-697	TARGET CORPORATION	—	May 15, 2024
49483-720	49483-720	TIME CAP LABORATORIES,INC	—	June 15, 2023

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.