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Premier Value Famotidine

Premier Value
Ranbaxy Pharmaceuticals Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT (IN EACH TABLET)

Famotidine USP, 10 mg

Famotidine USP, 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

Famotidine USP, 10 mg

  • with other acid reducers
  • 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.

Famotidine USP, 20 mg

  • with other acid reducers
  • 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.

Ask a doctor before use if you have

  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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

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 (1-800-222-1222).

DIRECTIONS

Famotidine USP, 10 mg

  • 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 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 USP, 20 mg

  • 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

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

INACTIVE INGREDIENTS

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (for 10 mg strength), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

call 1-800-406-7984

  • 1 tablet relieves heartburn due to acid indigestion
  • Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Tips for Managing Heartburn

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. (In Blister Carton)

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (In Bottle Carton)

TAMPER EVIDENT: DO NOT USE IF PRINTED FOIL UNDER CAP IS OPEN OR TORN. (In Stand-Alone Label)

See end panel for batch number and expiration date.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 34331

PRINCIPAL DISPLAY PANEL

Premier Value ®

NDC 68016-010-81

ORIGINAL STRENGTH

Famotidine Tablets USP, 10 mg

Acid Controller

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

30 Tablets

Compare to the active ingredient in Original Strength Pepcid ® AC

This product is not manufactured or distributed by Johnson & JohnsonMerck Consumer Pharmaceuticals Co., distributor of Pepcid ® AC. Pepcid ® AC is a registered trademark of Merck & Co., Inc.

Premier Value ®

NDC 68016-008-01

MAXIMUM STRENGTH

Famotidine Tablets USP, 20 mg

Acid Controller

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

25 Tablets

Compare to the active ingredient in Maximum Strength Pepcid ® AC

This product is not manufactured or distributed by Johnson & Johnson Merck Consumer Pharmaceuticals Co., distributor of Pepcid ® AC. Pepcid ® AC is a registered trademark of Merck & Co., Inc.

Premier Value Famotidine

Famotidine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-010
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
COLLOIDAL SILICON DIOXIDE
hydroxypropyl cellulose
HYPROMELLOSES
ferric oxide red
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
STARCH, PREGELATINIZED CORN
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
pink 8 mm 035 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68016-010-81 30 in 1 BLISTER PACK
2 NDC:68016-010-82 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090283 2010-06-25


Premier Value Famotidine

Famotidine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-008
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
COLLOIDAL SILICON DIOXIDE
hydroxypropyl cellulose
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
STARCH, PREGELATINIZED CORN
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 8 mm 036 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68016-008-01 25 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090283 2010-07-23


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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