FDA Label for Heartburn Relief
View Indications, Usage & Precautions
Heartburn Relief Product Label
The following document was submitted to the FDA by the labeler of this product Shield Pharmaceuticals Corp. 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.
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Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788
Active Ingredient (In Each Liquid-Filled Capsule)
Famotidine 10 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
Otc - 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
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you aretaking
a prescription drug. Acid reducers may interact with certain prescription drugs.
Otc - Stop Use
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.
Directions
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)
adults and children 12 years and over:
- to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
- 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
- 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
hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin
Questions Or Comments?
1-800-373-6981 (toll-free)
Principal Display Panel
Heartburn Relief
Famotidine Tablets 10 mg
Acid Reducer
Just One Tablet!
Prevents and Relieves Heartburn Due to Acid Indigestion
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