Active Ingredient (In Each Tablet)
Famotidine USP 10 mg and 20 mg
Famotidine Tablet, Film Coated
FDA Label NDC 83324-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Famotidine (NDC 83324-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
10 mg:
• to
preventsymptoms, swallow 1 tablet with a glass of water at any time from
15 to 60 minutes beforeeating food or drinking beverages that cause heartburn
20 mg:
• to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes beforeeating 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° to 25°C (68° to 77°F)
• protect from moisture
Inactive Ingredients
10 mg:
carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide.
20 mg:
carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, red iron oxide and yellow iron oxide.
Questions Or Comments?
1-888-375-3784
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
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
Principal Display Panel
Famotidine Tablets USP 10 mg - 30s container label
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Famotidine Tablets USP 10 mg - 30s container carton label
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Famotidine Tablets USP 20 mg - 50s container label
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Famotidine Tablets USP 20 mg - 50s container carton label
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