TAGAMET- cimetidine tablet

TAGAMET by

Drug Labeling and Warnings

TAGAMET by is a Otc medication manufactured, distributed, or labeled by Prestige Brands Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Keep carton for future reference.

Drug Facts

Active ingredient (in each tablet)

Cimetidine 200mg

Purpose

Acid reducer

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

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 (1-800-222-1222) right away.

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

Other information

store at 15-30ºC (59-86ºF)

Inactive ingredients

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?

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

PRINCIPAL DISPLAY PANEL

Tagamet® HB 200
Cimetidine Tablets 200 mg
Acid Reducer

30 tablets (30 doses)

INGREDIENTS AND APPEARANCE

TAGAMET 
cimetidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52183-223
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)	CIMETIDINE	200 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	blue	Score	2 pieces
Shape	DIAMOND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	TAGAMET;200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-223-30	3 in 1 BOX	02/01/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020238	02/01/2023

Labeler - Prestige Brands Holdings, Inc. (159655021)