FAMOTIDINE- famotidine tablet, film coated, extended release 
SPIRIT PHARMACEUTICALS,LLC

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HEARTBURN RELIEF

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10mg

Purpose

Acid reducer

Uses

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

Other 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)

Principal Display Panel - 12 Tablet Blister Pack Carton
FAMOTIDINE 
famotidine tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize8mm
FlavorImprint Code W972
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-0007-02 in 1 CARTON
16 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: 8/2013
Document Id: 0935b09d-5609-4cc5-a65c-e5da29bc9449
Set id: 84a9a761-7d6f-4e63-814f-e7a71e0ff11b
Version: 1
Effective Time: 20130823
 
SPIRIT PHARMACEUTICALS,LLC