Famotidine by Bi-Mart / VKT Pharma Private Limited FAMOTIDINE tablet

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, VKT Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Famotidine 10 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

• with other acid reducers
• 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.

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 wheezing, particularly with heartburn
• frequent chest pain
• unexplained weight loss
• nausea or vomiting
• stomach pain
• kidney disease

Ask a doctor or pharmacist before use if you aretaking 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 (1-800-222-1222) right away. 

Directions

• adults and children 12 years and over:
  • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
  • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating 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
• store at 20° - 25°C (68° - 77°F)
• protect from moisture

Inactive ingredients

Hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, polyethylene glycol, talc, titanium dioxide, triacetin.

Questions?

call toll-free 1-844-912-4012

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-161
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	V;21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-161-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215822	04/01/2025

Labeler - Bi-Mart (027630078)

Registrant - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
VKT Pharma Private Limited		871408062	manufacture(37835-161)