Label: FAMOTIDINE 20 MG tablet, coated
- NDC Code(s): 25000-124-68, 25000-124-84, 25000-124-94
- Packager: MARKSANS PHARMA LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 6, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
-
ASK A DOCTOR BEFORE USE IF
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
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
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
Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
•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
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India -
PRINCIPAL DISPLAY PANEL
NDC: 25000-124-94
Famotidine Tablets USP 20 mg- Cool mint flavor
25's (5 x 5's blister) count Carton Label
NDC: 25000-124-84
Famotidine Tablets USP 20 mg- Cool mint flavor
25's count Bottle Label
NDC: 25000-124-84
Famotidine Tablets USP 20 mg- Cool mint flavor
25's count Carton Label
NDC: 25000-124-68
Famotidine Tablets USP 20 mg- Cool mint flavor
300's count Bottle Label
-
INGREDIENTS AND APPEARANCE
FAMOTIDINE 20 MG
famotidine 20 mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-124 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARNAUBA WAX (UNII: R12CBM0EIZ) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) STARCH, CORN (UNII: O8232NY3SJ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor MINT Imprint Code 124 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-124-94 5 in 1 CARTON 05/23/2025 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:25000-124-84 1 in 1 CARTON 05/23/2025 2 25 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:25000-124-68 300 in 1 BOTTLE; Type 0: Not a Combination Product 05/23/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217543 05/23/2025 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-124)
