FAMOTIDINE- famotidine tablet, film coated 
GLENMARK THERAPEUTICS INC., USA

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Famotidine Tablets

Drug Facts

Active ingredient (in each tablet)

Famotidine, USP 10 mg and 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 a 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 medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years and over:
o
to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o
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
o
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
o
before eating food or drinking beverages that cause heartburn
o
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°C to 25°C (68°F to 77°F)
protect from moisture

Inactive ingredients

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol

Questions or comments?

Call us at 1 (888) 721-7115 (toll-free)

Distributed by: Glenmark Therapeutics Inc., USA
Mahwah, NJ 07430
Made in India
M.L. No.: 02/SKL/AP/2015/F/R

Revision: 04/22

Principal Display Panel

NDC 72657-112-90

Famotidine Tablets, USP 10mg

90 Tablets

carton10mg90

Principal Display Panel

NDC 72657-113-88

Famotidine Tablets, USP 20mg

85 Tablets

carton20mg85
FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize5mm
FlavorImprint Code V;21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72657-112-901 in 1 CARTON06/01/2022
190 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:72657-112-201 in 1 CARTON06/01/2022
2200 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582206/01/2022
FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code V;15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72657-113-881 in 1 CARTON06/01/2022
185 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:72657-113-201 in 1 CARTON06/01/2022
2200 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582206/01/2022
Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
Establishment
NameAddressID/FEIBusiness Operations
VKT Pharma Private Limited871408062MANUFACTURE(72657-112, 72657-113)

Revised: 5/2022
Document Id: ee1f9ca9-3c23-4662-8194-68ec5ea7a6bd
Set id: 95f51f27-d367-4cfd-a15f-7856c9e361fb
Version: 2
Effective Time: 20220509
 
GLENMARK THERAPEUTICS INC., USA