FAMOTIDINE   - famotidine tablet 
Bryant Ranch Prepack

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Active ingredient (in each tablets)

Famotidine USP 20 mg

Purpose

Acid reducer

Uses

Warnings

Do not use if you are allergic to famotidine or other acid reducers Allergy alert:

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
  • or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness chest pain
  • 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

ask a health professional before use. If pregnant or breast-feeding,

In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

Directions

Other information

Inactive ingredients

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

Questions or comments?

Call Wockhardt Limited, Mumbai, India. Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Iss.130810 1-800-346-6854

Manufactured by:



Distributed by:






Famotidine 20mg Tablet

Label Image

FAMOTIDINE  
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-2904(NDC:64679-374)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 
TALC 
MAGNESIUM STEARATE 
HYPROMELLOSES 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
Product Characteristics
Colorwhite (white) Score no score
ShapeROUND (barrel shaped) Size9mm
FlavorImprint Code W374
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63629-2904-130 TABLET ( TABLET) in 1 BOTTLENone
2NDC:63629-2904-260 TABLET ( TABLET) in 1 BOTTLENone
3NDC:63629-2904-320 TABLET ( TABLET) in 1 BOTTLENone
4NDC:63629-2904-490 TABLET ( TABLET) in 1 BOTTLENone
5NDC:63629-2904-5100 TABLET ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09083708/06/2010

Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK, RELABEL

Revised: 08/2010 Bryant Ranch Prepack