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simply right famotidine

Sam's West Inc

Sam’s West, Inc. Famotidine Tablets USP 20 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Famotidine 20 mg

Purpose

Acid reducer

simply right 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.
  • •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

simply right famotidine 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?

1-800-809-0469

Principal Display Panel

maximum strength

famotidine tablets USP 20 mg

acid reducer

Compare to Maximum Strength Pepcid® AC active ingredient

just one tablet prevents & relieves heartburn due to acid indigestion

actual size

200 TABLETS

(2-100 COUNT BOTTLES)

simply right famotidine

Famotidine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68196-299
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FAMOTIDINE FAMOTIDINE 20 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm L194 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68196-299-01 85 in 1 BOTTLE
2 NDC:68196-299-78 100 in 1 BOTTLE
3 NDC:68196-299-82 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077351 2012-01-26


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Be sure to consult your doctor before taking any medication!
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