FORMUCARE RANITIDINE - ranitidine hydrochloride tablet 
Access Business Group International LLC

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Access Business Group International LLC Ranitidine 75 Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 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 foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine 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.
• with other acid reducers

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.

Directions

• adults and children 12 years and over:
• to relieve symptoms, swallow 1 tablet with a glass of water
• to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
• can be used up to twice daily (do not take more than 2 tablets in 24 hours)
• children under 12 years: ask a doctor

Other information

• do not use if printed foil under cap is broken or missing
• store at 20° - 25°C (68° - 77°F)
• avoid excessive heat or humidity
• this product is sugar free

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.

Questions or comments?

1-800-719-9260

Principal Display Panel

Ranitidine 75

Ranitidine Tablets USP, 75 mg

Acid Reducer

Prevents and Relieves:

Heartburn Associated with Acid Indigestion and Sour Stomach

FORMUCARE RANITIDINE  ranitidine   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10056-271 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 75 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK Score no score Shape HEXAGON (6 sided) Size 8mm Flavor Imprint Code W;75 Contains

Packaging # NDC Package Description Multilevel Packaging 1 10056-271-27 1 BOTTLE In 1 CARTON contains a BOTTLE 1 80 TABLET In 1 BOTTLE This package is contained within the CARTON (10056-271-27)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076760	09/09/2009

Labeler - Access Business Group International LLC (609682641)

Revised: 09/2009Access Business Group International LLC