ACID REDUCER MAXIMUM STRENGTH - ranitidine hydrochloride tablet 
L Perrigo Company

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Perrigo Acid Reducer Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 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 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
• 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.

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 (Bottle Only)
• do not use if blister unit is broken or torn (Blister Only)
• avoid excessive heat or humidity
• store at 20° - 25°C (68° - 77°F)
• this product is sugar free

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C yellow #6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.

Questions or comments?

1-800-719-9260

Principal Display Panel

Maximum Strength

Ranitidine Tablets 150 mg

Acid Reducer

Prevents & Relieves

Heartburn

Acid Indigestion

Sour Stomach

Compare to active ingredient of Zantac 150®

(# Doses) {Replace "#" with the number of tablets in the package}

ACID REDUCER  MAXIMUM STRENGTH ranitidine   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0113-0047 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color ORANGE Score no score Shape HEXAGON (6 sided) Size 11mm Flavor Imprint Code W;741 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0113-0047-62 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 8 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0113-0047-62) 2 0113-0047-71 1 BOTTLE In 1 CARTON contains a BOTTLE 2 50 TABLET In 1 BOTTLE This package is contained within the CARTON (0113-0047-71)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078653	02/19/2008

Labeler - L Perrigo Company (006013346)

Revised: 05/2009L Perrigo Company