FAMOTIDINE- famotidine tablet, film coated 
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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

  • 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

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

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

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PATIENT INFORMATION

Tips for Managing Heartburn

PRINCIPAL DISPLAY PANEL

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NDC 15127-370-12

Original Strength

Acid Controller

Famotidine Tablets USP, 10 mg

Acid Reducer

Compare to the active ingredient of Original Strength Pepcid AC®

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

12 Tablets

Distributed by: SELECT BRAND®DISTRIBUTORS

5102118/R0413

10 mg, 12's blister carton label
FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:15127-370
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 035
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-370-121 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:15127-370-301 in 1 CARTON
230 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028302/13/2012
Labeler - Select Brand (043562370)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(15127-370)

Revised: 7/2013
Document Id: 14f9b3e4-d31d-4e20-a402-a2c84d11a3f1
Set id: 2a9153f1-3778-4f6f-b9b0-4c0bcaf49060
Version: 1
Effective Time: 20130718
 
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