FAMOTIDINE- famotidine tablet, film coated 
VKT Pharma Private Limited

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Famotidine tablet, film coated


Famotidine Tablets

Drug Facts

Active ingredient (in each tablet)

Famotidine USP, 10 mg and 20 mg

Purpose

Acid reducer

Uses

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

Other information

Inactive ingredients

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

Questions or comments?

1 844-387-1231 (toll-free)


Manufactured by:
VKT Pharma Private Limited

Srikakulam, India-532 409,
M.L. No.: 02/SKL/AP/2015/F/R

Repackaged  by:
Neeyaan LLC,
4 Corporate Dr,
Cranbury NJ 08512

Revision: 05/2024

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Famotidine Tablets, USP 10 mg NDC 71821-012-09 Bulk Label

image description

Famotidine Tablets, USP 20 mg NDC 71821-010-13 Bulk Label

image description

FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71821-012
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:71821-012-09288461 in 1 BAG; Type 0: Not a Combination Product05/23/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582205/23/2024
FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71821-010
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:71821-010-13144230 in 1 BAG; Type 0: Not a Combination Product05/23/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582205/23/2024
Labeler - VKT Pharma Private Limited (871408062)
Registrant - VKT Pharma Private Limited (871408062)
Establishment
NameAddressID/FEIBusiness Operations
VKT Pharma Private Limited871408062manufacture(71821-012, 71821-010)

Revised: 5/2024
Document Id: 6363f098-8bab-4879-bea8-41b60c4530eb
Set id: 1c2cfb3c-eaa0-403f-9589-d706afc06f51
Version: 1
Effective Time: 20240522
 
VKT Pharma Private Limited