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cimetidine

WALGREEN COMPANY

Walgreen Co. Cimetidine 200 Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Cimetidine 200 mg

Purpose

Acid reducer

cimetidine 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 food 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

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.

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.

Directions

  • •adults and children 12 years and over:
  • •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

  • •do not use if printed foil under cap is broken or missing
  • •store at 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Consumer Information

Cimetidine Tablets, 200 mg

Acid Reducer

For Heartburn

Just one Cimetidine Tablet, 200 mg relieves and prevents heartburn and acid indigestion.

This product reduces the production of stomach acid that can cause heartburn.

In clinical studies, Cimetidine Tablets, 200 mg was significantly better than placebo tablets in relieving and preventing heartburn symptoms.

And Cimetidine Tablets, 200 mg is approved to take before, during, or after a meal.

Percent of Heartburn Episodes Relieved

Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken 30 Minutes Before a Meal

Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken at Time of Meal

Drug Interaction Warnings:

This product 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), Warfarin (blood thinning medicine) or Phenytoin (seizure medicine), consult your doctor before taking this product.

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 this product on any other medicines you are taking, talk to your doctor or pharmacist.

For Prevention and Relief of Heartburn

  • To prevent heartburn symptoms, take Cimetidine Tablet, 200 mg before your first bite or any time up to 30 minutes before eating food or drinking beverages that may cause heartburn.
  • To relieve heartburn symptoms and for relief of acid indigestion and sour stomach, take Cimetidine Tablet, 200 mg at the first signs of discomfort.

Tips for Managing Heartburn

  • •Do not lie flat or bend over soon after eating
  • •Do not eat late at night, or just before bedtime
  • •Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
  • •Eat slowly and do not eat big meals
  • •If you are overweight, lose weight
  • •If you smoke, quit smoking
  • •Raise the head of your bed
  • •Wear loose fitting clothing around your stomach

READ THE LABEL

Read the directions and warnings before taking this medication.

Distributed By

Perrigo®

Allegan, MI 49010

perrigo.com

1-800-719-9260

Rev. Date: 11/08

02200 00 J4

Principal Display Panel

Cimetidine 200

Cimetidine Tablets USP, 200 mg / Acid Reducer

Just one tablet relieves & prevents heartburn & acid ingestion

Take before, during or after a meal

60 TABLETS (60 DOSES)

Actual Size

Compare to Tagamet HB 200® active ingredient

cimetidine

Cimetidine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0022
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
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 13 mm L022 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:0363-0022-72 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075285 2001-03-27


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Be sure to consult your doctor before taking any medication!
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