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TAGAMET

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Cimetidine 200 mg

Acid reducer

  • 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

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

Ask a doctor or pharmacist before use if you are taking

  • •theophylline (oral asthma medicine)
  • •warfarin (blood thinning medicine)
  • •phenytoin (seizure medicine)

If you are not sure you are taking one of these medicines, talk to your doctor or pharmacist.

Drug Interaction Warnings:

Tagamet HB 200® may interfere with the action of drugs prescribed by your doctor. Check with your doctor before taking Tagamet HB 200® if you are taking blood thinning medication (e.g. Warfarin) or drugs prescribed for asthma (e.g. Theophylline) or epilepsy (e.g. Phenytoin).

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

THEOPHYLLINE

THEO-DUR® Theochron® Slo-Bid® Uniphyl® Theo-24®

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.

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 right away.

    • ∘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
  • •store at 15-30oC (59-86oF)

Each tablet individually sealed in a blister pack. Do not use if blister or foil is open or torn.

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

call toll-free 1-800-482-4394 (English/Spanish) weekdays

Principal Display Panel

Tagamet HB 200®

Cimetidine Tablets 200 mg/Acid Reducer

30 TABLETS (30 DOSES)

Just ONE TABLET RELIEVES

and PREVENTS Heartburn and Acid Indigestion

Take ANY TIME you need it:

  • Before Meal
  • During Meal
  • After Meal

Read and retain the important drug interaction warnings printed on the inside of this carton

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Twp, PA 15108, Made in Spain

©2010 GlaxoSmithKline

TAGAMET HB 200® is a registered trademark of the GlaxoSmithKline group of companies.

For more information, visit tagamethb.com

100519IA

TAGAMET

cimetidine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0148
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CIMETIDINE CIMETIDINE 200 mg

Inactive Ingredients

Ingredient Name Strength
POWDERED CELLULOSE
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 13 mm TAGAMET;200 DIAMOND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0148-02 6 in 1 BLISTER PACK
2 NDC:0135-0148-05 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020238 2010-03-19


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Be sure to consult your doctor before taking any medication!
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