FAMOTIDINE tablet, film coated

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by Graviti Pharmaceuticals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH TABLET)

Original Strength

Drug Facts

Famotidine 10 mg

Maximum Strength

Drug Facts

Famotidine 20 mg

PURPOSE

Acid reducer

USES

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

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
• 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)

DIRECTIONS

Directions for 10 mg

• 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

Directions for 20 mg

• 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

• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20° - 25°C (68° - 77°F)
• protect from moisture

FDA approved dissolution test specifications differ from USP.

INACTIVE INGREDIENT

carnauba wax, corn starch, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc,

titanium dioxide.

For 10 mg: iron oxide black and iron oxide red,

For 20 mg: iron oxide yellow and iron oxide red.

DOSAGE & ADMINISTRATION

QUESTIONS OR COMMENTS?

Call toll-free weekdays 9 AM to 5 PM EST at 1-855-298-4506

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.

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet, film coated

Product 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 coated

Product 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)