CIMETIDINE ACID REDUCER- cimetidine tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)
Available from:
Walgreen Company
INN (International Name):
CIMETIDINE
Composition:
CIMETIDINE 200 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer
Authorization status:
Abbreviated New Drug Application
Authorization number:
0363-0022-72

CIMETIDINE ACID REDUCER- cimetidine tablet, film coated

Walgreen Company

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Walgreen Co. Cimetidine 200 Drug Facts

Active ingredient (in each tablet)

Cimetidine 200 mg

Purpos e

Acid reducer

Us es

Warnings

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

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking

Stop use and ask a doctor if

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

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

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

a prescription drug. Acid reducers may interact with certain prescription drugs.

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 (1-800-222-1222).

Directions

Other information

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

In clinical studies, Cimetidine Tablets, 200 mg was significantly better than placebo tablets in

relieving and preventing heartburn symptoms.

Percent of Heartburn Episodes Relieved

you need to take this product for more than 14 days

stomach pain continues

your heartburn continues or worsens

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

30minutes 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 20°-25°C (68°-77°F)

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:

Cimetidine Tablets, 200 mg 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 Cimetidine Tablets, 200 mg on any other medicines you are taking, talk to your

doctor or pharmacist.

Tips for Managing Heartburn

Read the directions and warnings before taking this medication.

Questions or Comments?

1-800-719-9260

Distributed By

Perrigo®

Allegan, MI 49010

Rev 08/19

02200 00 J5

Principal Display Panel

Compare to Tagamet HB 200 active ingredient

Cimetidine 200

CIMETIDINE TABLETS USP, 200 mg / ACID REDUCER

Just one tablet relieves & prevents heartburn & acid indigestion

Take before, during or after a meal

60 TABLETS (60 DOSES)

ACTUAL SIZE

READ AND RETAIN THE IMPORTANT INFORMATION AND DRUG INTERACTION

WARNINGS PRINTED ON THE PRODUCT INFORMATION SHEET

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

CIMETIDINE ACID REDUCER

cimetidine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 0 22

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CIMETIDINE (UNII: 8 0 0 6 1L1WGD) (CIMETIDINE - UNII:8 0 0 6 1L1WGD)

CIMETIDINE

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

13mm

Flavor

Imprint Code

L0 22

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-0 0 22-72

1 in 1 CARTON

0 4/14/20 10

1

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7528 5

0 3/27/20 0 1

Walgreen Company

Labeler -

Walgreen Company (008965063)

Revised: 1/2020

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