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FAMOTIDINE by SPIRIT PHARMACEUTICALS,LLC

Dosage form: tablet, film coated, extended release
Ingredients: FAMOTIDINE 10mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-0007

HEARTBURN RELIEF

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10mg

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
  • 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.
  • with other acid reducers

Ask a doctor before use if you have
  • 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

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.

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 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 25°-30°C (77°-86°F).
  • read the directions and warnings before use
  • protect from moisture.
  • keep the carton and package insert. They contain important information.

Inactive ingredients

hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions or comments?

1-800-xxx-xxxx

Distributed By: Greenbrier International, Inc.
Chesapeake, VA 23320

PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Pack Carton

ASSURED

Compare to the
active ingredient
in Pepcid® AC*

Original Strength
HEARTBURN
RELIEF

FAMOTIDINE TABLETS USP, 10 mg

ACID REDUCER

Just One Tablet Relieves &
Prevents Heartburn Due to
Acid Indigestion

12 TABLETS (12 DOSES)

FAMOTIDINE 
famotidine tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (TYPE H) 
TALC 
FERRIC OXIDE RED 
POLYETHYLENE GLYCOL 400 
CELLULOSE, MICROCRYSTALLINE 
WATER 
MAGNESIUM STEARATE 
HYPROMELLOSES 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize8mm
FlavorImprint CodeW972
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0007-02 BLISTER PACK in 1 CARTON
16 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07714608/19/2013
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Revised: 08/2013
 
SPIRIT PHARMACEUTICALS,LLC

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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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