Label: HEARTBURN RELIEF- famotidine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-448-01 - Packager: Select Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 14, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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DOSAGE & ADMINISTRATION
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 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
- INDICATIONS & USAGE
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WARNINGS
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
Stop use and ask a doctor if • your
heartburn continues or worsens • you
need to take this product for more than
14 days
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HEARTBURN RELIEF
famotidine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-448 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color pink (ROSE PINK) Score no score Shape ROUND (W972) Size 8mm Flavor Imprint Code W972 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-448-01 1 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077146 03/14/2014 Labeler - Select Corporation (053805599) Registrant - Select Corporation (053805599)