FAMOTIDINE- famotidine tablet 
Bryant Ranch Prepack

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FAMOTIDINE
Tablets USP
10 mg
ACID REDUCER

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10 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

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

colloidal silicon dioxide, FD & C Red #40 aluminum lake, FD & C Yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions?

call 1-888-838-2872, weekdays, 8 AM to 5 PM Eastern Time

Famotidine 10mg Tablet

Label
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63629-4593(NDC:0172-2662)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 10;2662
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-4593-130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07551202/18/2010
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-4593), RELABEL(63629-4593)

Revised: 1/2013
Document Id: e3d34142-b46e-42a4-af72-851cbe356216
Set id: 54dd59bc-bfcb-4992-9992-abd6cda43faa
Version: 1000
Effective Time: 20130121
 
Bryant Ranch Prepack