TAGAMET- cimetidine tablet

Tagamet by

Drug Labeling and Warnings

Tagamet by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

READ THE DIRECTIONS AND WARNINGS, INCLUDING THOSE PRINTED
ON THE INSIDE OF THE CARTON, BEFORE TAKING THIS PRODUCT.

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

• your heartburn continues or worsens
  
• stomach pain continues
  
• 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.

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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Questions? 

Call toll-free 1-800-482-4394       tagamet.com

Drug Interaction Warnings:

Tagamet HB 200®affects some prescription medicines causing slightly higher levels of those medicines in the blood. Higher blood levels could lead to side effects in rare situations. If you currently take Theophylline (oral asthma medicine), Warafin (blood thinning medicine) or Phenytoin (seizure medicine), consult your doctor before taking Tagamet HB 200®.

Brand names of some medicines which contain one of these ingredients include:

THEOPHYLLINE	THEO-DUR®; Uniphyl®	Theochron®; Theo-24®	Slo-Bid®
WARFARIN	Coumadin®
PHENYTOIN	Dilantin®

  

There may be other medicines that contain one of these ingredients. If in doubt about this or about possible effects of Tagamet HB 200® on any other medicines you are taking, talk to your doctor or pharmacist.

Read the directions and warnings before taking this medication.

PRINCIPAL DISPLAY PANEL

Tagamet® HB 200
Cimetidine Tablets 200 mg
Acid Reducer
40
TABLETS
(40 DOSES)

INGREDIENTS AND APPEARANCE

TAGAMET 
cimetidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-222
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
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STARCH, CORN (UNII: O8232NY3SJ)
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)

Product Characteristics
Color	WHITE	Score	no score
Shape	DIAMOND	Size	13mm
Flavor		Imprint Code	TAGAMET;200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-222-02	1 in 1 BOX	06/01/2012
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63029-222-01	1 in 1 BOX	06/01/2012
2		30 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 63029-222-03	1 in 1 BOX	06/01/2012
3		50 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 63029-222-04	4 in 1 BOX	06/01/2019
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 63029-222-05	4 in 1 BOX	06/01/2019
5		9 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	06/01/2012

Labeler - Medtech Products Inc. (122715688)