Famotidine

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Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP, 20 mg

PURPOSE

OTC - PURPOSE SECTION

Acid reducer

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do Not Use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - STOP USE SECTION

• your heartburn continues or worsens
• you need to take this product for more than 14 days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• store at 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.
• TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PATIENT INFORMATION

SPL UNCLASSIFIED SECTION

• 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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHOPKO^®

Compare to the Active Ingredient of Maximum Strength Pepcid_®AC^†

Maximum Strength

Acid Controller

Famotidine Tablets, USP 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

25 Tablets

Manufactured by: Ohm Laboratories Inc.

5091040/0212

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Products#

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• Famotidine
• COLLOIDAL SILICON DIOXIDE
• HYDROXYPROPYL CELLULOSE
• HYPROMELLOSES
• POLYETHYLENE GLYCOL 400
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• STARCH, PREGELATINIZED CORN
• TALC
• TITANIUM DIOXIDE

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