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Topcare Acid Reducer

Package insert / prescribing information
Generic name: famotidine
Dosage form: tablet
Drug class: H2 antagonists

Medically reviewed by Drugs.com. Last updated on Nov 1, 2021.

Active ingredient (in each tablet)

Famotidine 20 mg

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 food and beverages

Warnings

Allergy alert: Do not use if you are allergic to famotidine 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

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
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
kidney 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
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. (1-800-222-1222)

Directions

adults and children 12 years and over:
to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
do not use more than 2 tablets in 24 hours
children under 12 years: ask a doctor

Other information

read the directions and warnings before use
keep the carton. It contains important information.
store at 20°-25°C (68°-77°F)
protect from moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO MAXIMUM STRENGTH PEPCID® AC ACTIVE INGREDIENT

MAXIMUM STRENGTH

Acid Reducer

FAMOTIDINE TABLETS, 20 mg

ACID REDUCER

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

50 TABLETS

actual size

Topcare Acid Reducer
famotidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-194
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L194
Contains
Packaging
# Item Code Package Description
1 NDC:36800-194-71 1 BOTTLE in 1 CARTON
1 50 TABLET, FILM COATED in 1 BOTTLE
2 NDC:36800-194-51 8 BLISTER PACK in 1 CARTON
2 1 TABLET, FILM COATED in 1 BLISTER PACK
3 NDC:36800-194-02 25 BLISTER PACK in 1 CARTON
3 1 TABLET, FILM COATED in 1 BLISTER PACK
4 NDC:36800-194-78 1 BOTTLE in 1 CARTON
4 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077351 09/28/2006
Labeler - Topco Associates LLC (006935977)
Topco Associates LLC

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