FAMOTIDINE- famotidine tablet 
IVAX Pharmaceuticals, Inc.

----------

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

PRINCIPAL DISPLAY PANEL

Famotidine Tablets 10mg 30's Label

Famotidine Tablets 10mg 30's Label Text

NDC 0172-2662-46

Tamper-Evident

FAMOTIDINE
Tablets USP

10 mg

ACID REDUCER

30 TABLETS Just One Per Dose

TEVA

FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0172-2662
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 10;2662
Contains    
Packaging
#Item CodePackage Description
1NDC:0172-2662-4630 in 1 CARTON
1NDC:0172-2662-001 in 1 BLISTER PACK
2NDC:0172-2662-4850 in 1 CARTON
2NDC:0172-2662-001 in 1 BLISTER PACK
3NDC:0172-2662-7270 in 1 CARTON
3NDC:0172-2662-001 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07551202/18/2010
Labeler - IVAX Pharmaceuticals, Inc. (884075235)

Revised: 08/2012
Document Id: 5a28a0de-df53-4dfa-b42e-8f7e29660b70
Set id: bdd3079b-6956-41a6-beff-eadb455db11c
Version: 2
Effective Time: 20120828
 
IVAX Pharmaceuticals, Inc.