FAMOTIDINE - famotidine tablet 
WOCKHARDT LIMITED

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Famotidine Tablets, USP
20 mg


Drugs Facts

Active ingredient (in each tablets)

Famotidine USP 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.
  • if you have kidney disease, except under the advice and supervision of a 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

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.

Directions

Other information

Inactive ingredients

Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

Questions or comments?

Call 1-800-346-6854

Manufactured by:
Wockhardt Limited,
Mumbai, India.

Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.

Iss.130810

Famotidine 20 mg_OTC_500's Bottle Label

Famotidine 20 mg_OTC_500's Bottle Carton
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-374
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (barrel shaped) Size9mm
FlavorImprint Code W374
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-374-011 in 1 CARTON
130 in 1 BOTTLE
2NDC:55648-374-081 in 1 CARTON
230 in 1 BOTTLE
3NDC:55648-374-051 in 1 CARTON
3500 in 1 BOTTLE
4NDC:55648-374-0710 in 1 CARTON
410 in 1 BLISTER PACK
5NDC:55648-374-0038000 in 1 DRUM
6NDC:55648-374-096500 in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09083708/06/2010
Labeler - WOCKHARDT LIMITED (650069115)

Revised: 8/2012
Document Id: d0e9c888-c641-40a8-9338-d83b6de02385
Set id: fdff466f-9884-4bbd-89af-0e186a54801b
Version: 2
Effective Time: 20120807
 
WOCKHARDT LIMITED