Label: FAMOTIDINE tablet
- NDC Code(s): 21130-191-20
- Packager: SAFEWAY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Uses
- Allergy alert
- Do not use
-
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 lighteasdedness, sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chestpain
- 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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children
-
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
- Inactive Ingredients
- Questions or Comments?
- PDP
-
INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-191 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) TRIACETIN (UNII: XHX3C3X673) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 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:21130-191-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215822 06/30/2023 Labeler - SAFEWAY (009137209)