Label: FAMOTIDINE tablet, film coated
- NDC Code(s): 55681-341-03, 55681-342-03
- Packager: TWIN MED LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 18, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
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.
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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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
- to prevent symptoms, swallow 1 tablet (of 20 mg) 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
- adults and children 12 years and over:
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55681-342 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 20 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code V;15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55681-342-03 300 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215822 01/28/2022 FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55681-341 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code V;15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55681-341-03 300 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215822 01/28/2022 Labeler - TWIN MED LLC (009579330)