Famotidine Tablets, USP 20 mg

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SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredient (in each tablets)

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-346-6854

Manufactured by:
Wockhardt Limited,
Mumbai, India.

Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.

Iss.130810

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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DailyMed product names page 1 of 1 · 9 matching rows.

• FAMOTIDINE
• CELLULOSE, MICROCRYSTALLINE
• STARCH, CORN
• HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
• TALC
• MAGNESIUM STEARATE
• HYPROMELLOSE 2910 (6 MPA.S)
• TITANIUM DIOXIDE
• POLYETHYLENE GLYCOL 400

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