MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH - famotidine tablet 
Major Pharmaceuticals

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Major Pharmaceuticals Heartburn Relief Drug Facts

Active ingredient (in each tablet)

Famotidine 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

• 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

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?

1-800-719-9260

Principal Display Panel

Maximum Strength

Heartburn Relief

Famotidine Tablets, 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

Compare to the active ingredient of Maximum Strength Pepcid® AC

Actual Size

Tablets

MAJOR HEARTBURN RELIEF  MAXIMUM STRENGTH famotidine   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-5780 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 8mm Flavor Imprint Code L194 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0904-5780-51 1 BOTTLE In 1 CARTON contains a BOTTLE 1 50 TABLET In 1 BOTTLE This package is contained within the CARTON (0904-5780-51) 2 0904-5780-17 5 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 5 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0904-5780-17)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077351	09/29/2006

Labeler - Major Pharmaceuticals (191427277)

Revised: 07/2009Major Pharmaceuticals