Famotidine Tablets 20 mg Drug Facts

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FAMOTIDINE- famotidine tablet 
Safecor Health, LLC

----------

Famotidine Tablets 20 mg Drug Facts

Active ingredient (in each tablet)

Famotidine 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

  • 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
  • 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 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

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

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide

Questions or comments?

1-800-447-1006

Principal Display Panel

Famotidine 20 mg Robot Unit Dose Box Label
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 48433-325(NDC: 49035-650)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 48433-325-10100 in 1 BOX, UNIT-DOSE09/30/201411/11/2019
1NDC: 48433-325-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735109/30/201411/11/2019
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675REPACK(48433-325)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC078805287REPACK(48433-325)

Revised: 11/2019
Document Id: 239120b1-ef59-46be-8097-0ec694e967f7
Set id: 351a8502-fa66-4aea-ba79-cfa050332c51
Version: 2
Effective Time: 20191123
 
Safecor Health, LLC