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 Type HUMAN OTC DRUG Item Code (Source) NDC:15127-370
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 035
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:15127-370-12 1 in 1 CARTON
1 12 in 1 BLISTER PACK
2 NDC:15127-370-30 1 in 1 CARTON
2 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090283 02/13/2012
Labeler - Select Brand (043562370)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(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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