Label: FAMOTIDINE tablet, film coated
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NDC Code(s):
69844-097-01,
69844-097-02,
69844-097-04,
69844-098-01, view more69844-098-02, 69844-098-04
- Packager: Graviti Pharmaceuticals Private Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2024
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
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WARNINGS
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
- kidney disease
Ask a doctor or pharmacist before use if you are taking prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if
• your heartburn continues or worsens
• you need to take this product for more than 14 days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get a medical help or contact a Poison Control Center right away. (1-800-222-1222)
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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 with a glass of water at any time from 15 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:
- 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 INGREDIENT
- DOSAGE & ADMINISTRATION
- QUESTIONS OR COMMENTS?
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - 10 mg Tablet: Container Label
NDC 69844-097-01
Original Strength
*Compare to the active ingredient in Pepcid AC®
Famotidine Tablet, USP 10 mg
Acid Reducer
Just One Tablet!
Prevent & Relives Heartburn Due to Acid Indigestion
30 Tablets
Marketed by Graviti Pharmaceuticals Inc.
Made in India.
Principal Display Panel - 10 mg Tablet: Carton Label
NDC 69844-097-01
Original Strength
*Compare to the active ingredient in Pepcid AC®
Famotidine Tablet, USP 10 mg
Acid Reducer
Just One Tablet!
Prevent & Relives Heartburn Due to Acid Indigestion
30's Tablets Bottles pack
Marketed by Graviti Pharmaceuticals Inc.
Made in India.
Principal Display Panel - 10 mg Tablet: Carton Label
NDC 69844-097-04
Original Strength
*Compare to the active ingredient in Pepcid AC®
Famotidine Tablet, USP 10 mg
Acid Reducer
Just One Tablet!
Prevent & Relives Heartburn Due to Acid Indigestion
10's Blister Pack
Marketed by Graviti Pharmaceuticals Inc.
Made in India.
Principal Display Panel - 20 mg Tablets: Container Label
NDC 69844-098-01
Maximum Strength
*Compare to the active ingredient in Pepcid AC®
Famotidine Tablet, USP 20 mg
Acid Reducer
Just One Tablet!
Prevent & Relives Heartburn Due to Acid Indigestion
30 Tablets
Marketed by Graviti Pharmaceuticals Inc.
Made in India.
Principal Display Panel - 20 mg Tablets: Carton Label
NDC 69844-098-01
Maximum Strength
*Compare to the active ingredient in Pepcid AC®
Famotidine Tablet, USP 20 mg
Acid Reducer
Just One Tablet!
Prevent & Relives Heartburn Due to Acid Indigestion
30's Tablets Bottle Pack
Marketed by Graviti Pharmaceuticals Inc.
Made in India.
Principal Display Panel - 20 mg Tablets: Carton Label
NDC 69844-098-04
Maximum Strength
*Compare to the active ingredient in Pepcid AC®
Famotidine Tablet, USP 20 mg
Acid Reducer
Just One Tablet!
Prevent & Relives Heartburn Due to Acid Indigestion
10's Blister Pack
Marketed by Graviti Pharmaceuticals Inc.
Made in India.
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INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69844-097 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 STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) CARNAUBA WAX (UNII: R12CBM0EIZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Product Characteristics Color PINK (Light pink to pink) Score no score Shape ROUND (rounded square biconvex) Size 5mm Flavor Imprint Code 60 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69844-097-01 1 in 1 CARTON 03/14/2024 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69844-097-02 1 in 1 CARTON 03/14/2024 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69844-097-04 18 in 1 CARTON 03/14/2024 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218461 03/14/2024 FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69844-098 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 STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) CARNAUBA WAX (UNII: R12CBM0EIZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color YELLOW (Light yellow) Score no score Shape ROUND (rounded square biconvex) Size 5mm Flavor Imprint Code 35 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69844-098-01 1 in 1 CARTON 03/14/2024 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69844-098-02 1 in 1 CARTON 03/14/2024 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69844-098-04 20 in 1 CARTON 03/14/2024 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218461 03/14/2024 Labeler - Graviti Pharmaceuticals Private Limited (650884781) Registrant - Graviti Pharmaceuticals Private Limited (650884781) Establishment Name Address ID/FEI Business Operations Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE(69844-097, 69844-098) , ANALYSIS(69844-097, 69844-098)