FDA Label for Famotidine 20 Mg
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
Famotidine 20 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Marksans Pharma Limited. 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.
Active Ingredient(S)
Active ingredient (in each tablet)
Famotidine USP 20 mg
Purpose
Purpose
Acid reducer
Use(S)
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
Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do Not Use
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
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
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 Doctor If
Stop use and ask a doctor if
•your heartburn continues or worsens
•you need to take this product for more than 14 days
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
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
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
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
•Meets USP dissolution test 2
Inactive Ingredients
Inactive ingredients carnauba wax, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium saccharin, talc, titanium dioxide
Questions Or Comments
Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
•JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
Tips for Managing Heartburn
•Do not lie flat or bend over after eating
•Do not wear tight-fitting clothing around the stomach
•Do not eat before bedtime
•Raise the head of your bed
•Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
•Eat slowly and avoid big meals
•If overweight, lose weight
•Quit smoking
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India
Principal Display Panel
NDC: 25000-124-94
Famotidine Tablets USP 20 mg- Cool mint flavor
25's (5 x 5's blister) count Carton Label
NDC: 25000-124-84
Famotidine Tablets USP 20 mg- Cool mint flavor
25's count Bottle Label
NDC: 25000-124-84
Famotidine Tablets USP 20 mg- Cool mint flavor
25's count Carton Label
NDC: 25000-124-68
Famotidine Tablets USP 20 mg- Cool mint flavor
300's count Bottle Label
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