FDA Label for Famotidine
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- ALLERGY ALERT
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 10 MG TABLET BLISTER PACK CARTON
- PRINCIPAL DISPLAY PANEL - 20 MG TABLET BOTTLE CARTON
Famotidine Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DISTRIBUTED BY DRUG MART-FOOD FAIR
MEDINA, OHIO 44256
Active Ingredient (In Each Tablet)
Famotidine, USP 10 mg
Famotidine, USP 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
Allergy Alert
Do not use if you are allergic to famotidine or other acid reducers
Do Not Use
Famotidine USP, 10 mg
- with other acid reducers
- 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
- if you have kidney disease, except under the advice and supervision of a doctor.
- 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.
Famotidine USP, 20 mg
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
Stop Use And Ask A Doctor If
- your heartburn continues or worsens
- you need to take this product for more than 14 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
Famotidine USP, 10 mg
- 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 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
- 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
Famotidine USP, 20 mg
Other Information
- store at 20° to 25° C (68° to 77° F)
- protect from moisture
- read the directions and warnings before use
- keep the carton. It contains important information.
Inactive Ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (only for Famotidine USP, 10 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide
Questions?
call 1-800-406-7984
Principal Display Panel - 10 Mg Tablet Blister Pack Carton
DISCOUNT
drug
mart
FOOD FAIR
MAY CONTAIN
ANTI-THEFT
DEVICE
Original Strength
ACID CONTROLLER
Famotidine Tablets, USP 10 mg
Acid Reducer
Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion
*COMPARE TO THE ACTIVE INGREDIENT OF ORIGINAL STRENGTH PEPCID AC®
30 TABLETS
Principal Display Panel - 20 Mg Tablet Bottle Carton
DISCOUNT
drug
mart
FOOD FAIR
MAY CONTAIN
ANTI-THEFT
DEVICE
Maximum Strength
ACID CONTROLLER
Famotidine Tablets, USP 20 mg
Acid Reducer
Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion
*COMPARE TO THE ACTIVE INGREDIENT OF MAXIMUM STRENGTH PEPCID AC®
25 TABLETS
* Please review the disclaimer below.