Premier Value Famotidine

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

Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Famotidine USP, 10 mg

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

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 trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • if you have kidney disease, except under the advice and supervision of a 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

  • 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 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

Famotidine USP, 20 mg

  • 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 to60 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 between 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, iron oxide red (for 10 mg strength), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

call 1-800-406-7984

  • 1 tablet relieves heartburn due to acid indigestion
  • Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Tips for Managing Heartburn

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. (In Blister Carton)

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (In Bottle Carton)

TAMPER EVIDENT: DO NOT USE IF PRINTED FOIL UNDER CAP IS OPEN OR TORN. (In Stand-Alone Label)

See end panel for batch number and expiration date.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 34331

PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-010-81

ORIGINAL STRENGTH

Famotidine Tablets USP, 10 mg

Acid Controller

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

30 Tablets

Compare to the active ingredient in Original Strength Pepcid®AC

This product is not manufactured or distributed by Johnson & JohnsonMerck Consumer Pharmaceuticals Co., distributor of Pepcid®AC. Pepcid®AC is a registered trademark of Merck & Co., Inc.

Premier Value®

NDC 68016-008-01

MAXIMUM STRENGTH

Famotidine Tablets USP, 20 mg

Acid Controller

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

25 Tablets

Compare to the active ingredient in Maximum Strength Pepcid®AC

This product is not manufactured or distributed by Johnson & Johnson Merck Consumer Pharmaceuticals Co., distributor of Pepcid®AC. Pepcid®AC is a registered trademark of Merck & Co., Inc.

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
COLLOIDAL SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code035
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-010-8130 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
2NDC:68016-010-8260 TABLET, FILM COATED (TABLET) 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
COLLOIDAL SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code036
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-008-0125 TABLET, FILM COATED (TABLET) 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

Revised: 05/2012
 
Premier Value

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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