TAGAMET

Manufacturer: Prestige Brands Holdings, Inc.
Effective date: 2023-01-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:53:37

Label at a glance#

ProductTAGAMET

Active ingredientCIMETIDINE

Label structure10 sections

Indications and 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

Dosage and administration

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-482-4394

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Keep carton for future reference.

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cimetidine 200mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to cimetidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you need to take this product for more than 14 days
stomach pain continues
your heartburn continues or worsens

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

store at 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, corn starch, FD&C Blue #1 Lake, flavor, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-800-482-4394 weekdays

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tagamet® HB 200
Cimetidine Tablets 200 mg
Acid Reducer

30 tablets (30 doses)

PRINCIPAL DISPLAY PANEL Tagamet® HB 200 Cimetidine Tablets 200 mg Acid Reducer Icy Cool Mint Flavor 30 tablets (30 doses)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197505	cimetidine 200 MG Oral Tablet	PSN	1
104062	Tagamet HB 200 MG Oral Tablet	PSN	1
104062	cimetidine 200 MG Oral Tablet [Tagamet]	SBD	1
197505	cimetidine 200 MG Oral Tablet	SCD	1
104062	Tagamet 200 MG Oral Tablet	SY	1
104062	Tagamet HB 200 MG Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CIMETIDINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f48ba86-02a3-4def-9efa-3a8140fd7adf	Product name	2	20250624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52183-223-30	TAGAMET	10 in 1 BLISTER PACK	TABLET	10		1
52183-223-30	TAGAMET	3 in 1 BOX	TABLET	3		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52183-223	TAGAMET (CIMETIDINE) TABLET [PRESTIGE BRANDS HOLDINGS, INC.]	1	Current NDC, 2 package rows	20230201_c8ba8815-9d99-439f-b397-3869f729d9f4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

TAGAMET
cimetidine
STARCH, CORN
FD&C BLUE NO. 1 ALUMINUM LAKE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52183-223	52183-223-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CIMETIDINE	80061L1WGD	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020238-001	TAGAMET HB	CIMETIDINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-06-19
N020238-002	TAGAMET HB	CIMETIDINE	200MG	TABLET / ORAL		RLD, RS	1996-08-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020238-001	TAGAMET HB	100MG	TABLET / ORAL	RLD	1995-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020238-001	TAGAMET HB	100MG	TABLET / ORAL	RLD	1995-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`4b0b4de00fa7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TAGAMET	CIMETIDINE	Prestige Brands Holdings, Inc.	c8ba8815-9d99-439f-b397-3869f729d9f4	2023-01-20	Warnings	Exact identifier ndc (package): 52183-223-30 ndc (product): 52183-223 ndc11 (package): 52183022330 spl id: e042ef55-48d2-43c6-91d1-55becd1f9f7c spl set id: c8ba8815-9d99-439f-b397-3869f729d9f4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.