Tagamet — Tablet

Overview

Brand name

Tagamet

Generic name

Cimetidine

Dosage form

Tablet

Route

Oral

Marketing category

NDA · NDA

Labeler

Medtech Products Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

3

Packages

12

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

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

15

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

020238

Application type

NDA · New Drug Application

Approval date

June 19, 1995

Sponsor

MEDTECH PRODUCTS

Products on application

2

Submissions recorded

20

Products approved under application 020238.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
020238-001	TAGAMET HB	TABLET		CIMETIDINE	Discontinued	—	RLD
020238-002	TAGAMET HB	TABLET		CIMETIDINE	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 020238.
Type	No.	Action	Status	Date	Review
Supplement	26	Manufacturing (CMC)	Approved	May 24, 2022	N/A
Supplement	25	Manufacturing (CMC)	Approved	March 15, 2021	N/A
Supplement	24	Labeling	Approved	April 13, 2020	Standard
Supplement	23	Labeling	Approved	March 26, 2019	Standard
Supplement	20	Manufacturing (CMC)	Approved	September 26, 2014	Standard
Supplement	17	Labeling	Approved	February 6, 2008	Standard
Supplement	15	Manufacturing (CMC)	Approved	October 4, 2006	Standard
Supplement	13	Labeling	Approved	May 10, 2005	Standard
Supplement	12	Manufacturing (CMC)	Approved	August 11, 1999	Standard
Supplement	11	Manufacturing (CMC)	Approved	May 14, 1999	Standard
Supplement	9	Manufacturing (CMC)	Approved	December 10, 1998	Standard
Supplement	10	Manufacturing (CMC)	Approved	November 6, 1998	Standard
Supplement	6	Efficacy	Approved	June 5, 1998	Unknown
Supplement	7	Manufacturing (CMC)	Approved	March 5, 1998	Standard
Supplement	5	Manufacturing (CMC)	Approved	April 15, 1997	Standard
Supplement	1	Manufacturing (CMC)	Approved	August 21, 1996	Standard
Supplement	2	Manufacturing (CMC)	Approved	July 23, 1996	Standard
Supplement	3	Labeling	Approved	March 29, 1996	Standard
Supplement	4	Efficacy	Approved	November 15, 1995	Unknown
Original application	1	Type 8 - Partial Rx to OTC Switch	Approved	June 19, 1995	Standard

Review documents

0 · Supplement · June 1, 2022
0 · Supplement · May 25, 2022
0 · Supplement · June 30, 2021
0 · Supplement · June 28, 2021
0 · Supplement · April 14, 2020
0 · Supplement · April 14, 2020
0 · Supplement · March 27, 2019
0 · Supplement · March 27, 2019
0 · Supplement · July 30, 2008
0 · Supplement · February 13, 2008
0 · Supplement · October 5, 2006
0 · Supplement · May 17, 2005
0 · Supplement · May 17, 2005

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240610). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240610 HUMAN OTC DRUG · 20230120

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 older: ▪ to relieve symptoms, swallow 1 tablet with a glass of water ▪ to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn ▪ do not take more than 2 tablets in 24 hours children under 12 years: ask a doctor

Warnings

openFDA Drug Labeling

Warnings Allergy a lert: 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 (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 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 200mg

Adverse event reports

Source: openFDA FAERS

9,668

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: CIMETIDINE. 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
63029-222-01	63029-222	Medtech Products Inc.	1 BLISTER PACK in 1 BOX (63029-222-01) / 30 TABLET in 1 BLISTER PACK	June 1, 2012
63029-222-02	63029-222	Medtech Products Inc.	1 BLISTER PACK in 1 BOX (63029-222-02) / 6 TABLET in 1 BLISTER PACK	June 1, 2012
63029-222-03	63029-222	Medtech Products Inc.	1 BLISTER PACK in 1 BOX (63029-222-03) / 50 TABLET in 1 BLISTER PACK	June 1, 2012
63029-222-04	63029-222	Medtech Products Inc.	4 BLISTER PACK in 1 BOX (63029-222-04) / 10 TABLET in 1 BLISTER PACK	June 1, 2019
63029-222-05	63029-222	Medtech Products Inc.	4 BLISTER PACK in 1 BOX (63029-222-05) / 9 TABLET in 1 BLISTER PACK	June 1, 2019
63029-222-06	63029-222	Medtech Products Inc.	7 BLISTER PACK in 1 BOX (63029-222-06) / 10 TABLET in 1 BLISTER PACK	June 1, 2012
63029-222-09	63029-222	Medtech Products Inc.	1 BOTTLE in 1 CARTON (63029-222-09) / 90 TABLET in 1 BOTTLE	June 1, 2012
63029-222-11	63029-222	Medtech Products Inc.	1 BOTTLE in 1 CARTON (63029-222-11) / 100 TABLET in 1 BOTTLE	June 1, 2012
63029-222-12	63029-222	Medtech Products Inc.	2 BLISTER PACK in 1 BOX (63029-222-12) / 6 TABLET in 1 BLISTER PACK	June 1, 2012
63029-222-70	63029-222	Medtech Products Inc.	1 BOTTLE in 1 CARTON (63029-222-70) / 70 TABLET in 1 BOTTLE	June 1, 2012
63029-223-30	63029-223	Medtech Products Inc.	3 BLISTER PACK in 1 BOX (63029-223-30) / 10 TABLET in 1 BLISTER PACK	February 1, 2023
52183-223-30	52183-223	Prestige Brands Holdings, Inc.	3 BLISTER PACK in 1 BOX (52183-223-30) / 10 TABLET in 1 BLISTER PACK	February 1, 2023
63029-222	63029-222	Medtech Products Inc.	—	June 1, 2012
63029-223	63029-223	Medtech Products Inc.	—	February 1, 2023
52183-223	52183-223	Prestige Brands Holdings, Inc.	—	February 1, 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 · 11 sections on this page.