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Premier Value Famotidine

Dosage form: tablet, film coated
Ingredients: FAMOTIDINE 10mg
Labeler: Premier Value
NDC Code: 68016-010

Premier Value® Famotidine

Drug Facts

Active ingredient (in each tablet)

Famotidine, USP 20 mg

Purpose

Acid reducer

Uses
  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

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
  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
    • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • store at 20° to 25° C (68° to 77° F)
  • protect from moisture
  • read the directions and warnings before use
  • keep the carton. It contains important 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 Blister Pack 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 Label

NDC 68016-008-01

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

PREMIER VALUE FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE (1200000 MW) 
HYPROMELLOSE, UNSPECIFIED 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL 400 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code035
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-010-8130 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:68016-010-8260 TABLET, FILM COATED in 1 BOTTLE
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE (1200000 MW) 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL 400 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code036
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-008-0125 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028307/23/2010
Labeler - Premier Value (101668460)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029manufacture(68016-010, 68016-008)

 
Premier Value

Medically reviewed on Aug 22, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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