FAMOTIDINE - ACID CONTROLLER- famotidine tablet, film coated 
WinCo Foods, LLC

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Famotidine - Acid Controller

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?

or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Carton

*Compare to the active ingredient in PEPCID AC® Original Strength

WinCo™
FOODS
ORIGINAL STRENGTH
Acid Controller

FAMOTIDINE TABLETS,
USP 10 mg/
ACID REDUCER
JUST ONE TABLET Prevents & Relieves Heartburn
Due to Acid Indigestion

30
Tablets

PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton

*Compare to the active ingredient in PEPCID AC® Maximum Strength

WinCo™
FOODS
MAXIMUM STRENGTH
Acid Controller

FAMOTIDINE TABLETS,
USP 20 mg/
ACID REDUCER
JUST ONE TABLET Prevents & Relieves Heartburn
Due to Acid Indigestion

25
Tablets

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton
FAMOTIDINE - ACID CONTROLLER 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-242
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, 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:67091-242-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028305/01/2012
FAMOTIDINE - ACID CONTROLLER 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-241
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 036
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-241-2525 in 1 BOTTLE; Type 0: Not a Combination Product01/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028305/01/2012
Labeler - WinCo Foods, LLC (056098817)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(67091-241, 67091-242)

Revised: 9/2018
Document Id: cbd2d399-dc7a-4f57-bf80-94b83b64d217
Set id: d622b654-bd85-4da9-aeaa-3c6a362e5b0b
Version: 3
Effective Time: 20180912
 
WinCo Foods, LLC