FAMOTIDINE- famotidine tablet, film coated 
Kinray

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Famotidine USP, 10 mg

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

Famotidine USP, 10 mg

  • 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.

Famotidine USP, 20 mg

  • with other acid reducers
  • if you have kidney disease, except under the advice and supervision of a doctor.
  • 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

Famotidine USP, 10 mg

Famotidine USP, 20 mg

OTHER INFORMATION

INACTIVE INGREDIENTS

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (only for Famotidine USP, 10 mg), 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

Preferred Plus Pharmacy

Compare to the active ingredient of Original Strength Pepcid® AC

ORIGINAL STRENGTH

Acid Controller

Famotidine Tablets USP, 10 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

30 Tablets

Distributed By: Kinray, Inc.

5086088/0411

This is the 30 count blister carton label for Preferred Plus Famotidine Tablets USP, 10 mg.

Preferred Plus Pharmacy

Compare to the active ingredient of Maximum Strength Pepcid®AC

MAXIMUM STRENGTH

Acid Controller

Famotidine Tablets USP, 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

25 Tablets

Distributed By: Kinray, Inc.

5091314/1111

This is the 25 count blister carton label for Preferred Plus Famotidine tablets USP, 20 mg.

FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-063
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 035
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-063-301 in 1 CARTON
130 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028310/03/2011
FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-064
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 036
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-064-251 in 1 CARTON
125 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028302/15/2012
Labeler - Kinray (012574513)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(61715-063, 61715-064)

Revised: 6/2013
Document Id: c72f6118-d58c-46ae-87b1-107a47113237
Set id: 3545b503-bcc1-4ca3-83c6-abe04f87c6c6
Version: 1
Effective Time: 20130626
 
Kinray