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FAMOTIDINE

IVAX Pharmaceuticals, Inc.

FAMOTIDINE Tablets USP 10 mg ACID REDUCER


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10 mg

Purpose

Acid reducer

FAMOTIDINE 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

FAMOTIDINE 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

Famotidine Tablets 10 mg 30's Carton Text

Prevents and Relieves Heartburn Due to Acid

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 Type Human otc drug label Item Code (Source) NDC:0172-2662
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FAMOTIDINE FAMOTIDINE 10 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
ORANGE (PEACH) 9 mm 10;2662 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0172-2662-00 1 in 1 BLISTER PACK
2 NDC:0172-2662-00 1 in 1 BLISTER PACK
3 NDC:0172-2662-00 1 in 1 BLISTER PACK
4 NDC:0172-2662-72 70 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075512 2010-02-18


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Be sure to consult your doctor before taking any medication!
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