PREMIER VALUE FAMOTIDINE- famotidine tablet, film coated 
Premier Value

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Premier Value® Famotidine

Drug Facts

Active ingredient (in each tablet)

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

  • 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

Other information

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions?

call 1-800-406-7984

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

COMPARE TO THE ACTIVE INGREDIENT
IN MAXIMUM STRENGTH PEPCID AC®

Premier
Value ®

MAXIMUM STRENGTH
Famotidine Tablets, USP 20 mg
Acid Controller

Acid Reducer

Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion

25 Tablets

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Label

Premier
Value ®

MAXIMUM STRENGTH
Famotidine Tablets, USP 20 mg
Acid
Controller

Acid Reducer

Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion

25 Tablets

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Label
PREMIER VALUE FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-010
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 (1600000 WAMW) (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:68016-010-8130 in 1 BLISTER PACK; Type 0: Not a Combination Product06/25/2010
2NDC:68016-010-8260 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028306/25/2010
PREMIER VALUE FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-008
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 (1600000 WAMW) (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:68016-008-0125 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028307/23/2010
Labeler - Premier Value (101668460)
Registrant - Sun Pharmaceutical Industries Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(68016-010, 68016-008)

Revised: 12/2019
Document Id: 7ab337e1-90e1-4233-b854-19aee40ccfbe
Set id: 42d1e2f2-9b9b-4a6d-9fc1-047e167153b5
Version: 4
Effective Time: 20191227
 
Premier Value