FAMOTIDINE- famotidine tablet 
Bryant Ranch Prepack

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FAMOTIDINE
Tablets USP
10 mg
ACID REDUCER

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10 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

  • 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 at any time from 15 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

  • read the directions and warnings before use
  • TAMPER-EVIDENT: Do not use this product if carton has been opened, if blister backing appears to have been disturbed, or if individual blister units are broken or torn.
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)
  • protect from moisture

Inactive ingredients

colloidal silicon dioxide, FD & C Red #40 aluminum lake, FD & C Yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions?

call 1-888-838-2872, weekdays, 8 AM to 5 PM Eastern Time

HOW SUPPLIED

Product: 63629-4593

Famotidine 10mg Tablet

Label Image
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-4593(NDC:0172-2662)
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 10;2662
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-4593-130 in 1 BOTTLE; Type 0: Not a Combination Product02/18/201012/31/2017
2NDC:63629-4593-260 in 1 BOTTLE; Type 0: Not a Combination Product02/18/201012/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07551202/18/201012/31/2017
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-4593) , RELABEL(63629-4593)

Revised: 11/2018
Document Id: 369dcf13-5278-463f-a92b-eed42c2f022a
Set id: 54dd59bc-bfcb-4992-9992-abd6cda43faa
Version: 1004
Effective Time: 20181126
 
Bryant Ranch Prepack