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Name:Acid Reducermaximum Strength
Manufacturer:Meijer Distribution Inc
Category:Over-the-counter (OTC) Marketed Drugs


Meijer Distribution, Inc. Acid Reducer Drug Facts

ACID REDUCER MAXIMUM STRENGTH - ranitidine hydrochloride tablet 
Meijer Distribution Inc

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Meijer Distribution, Inc. 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
  • 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

Consumer Information

What you should know about

MAXIMUM STRENGTH

Ranitidine Tablets USP, 150 mg

Acid Reducer

(Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets 150 mg. Save this leaflet for future reference.)

What are MAXIMUM STRENGTH Ranitidine Tablets 150 mg?

  • MAXIMUM STRENGTH Ranitidine Tablets 150 mg contain 150 mg of ranitidine (as ranitidine hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

What symptoms do MAXIMUM STRENGTH Ranitidine Tablets 150 mg treat and prevent?

MAXIMUM STRENGTH Ranitidine Tablets 150 mg relieve and prevent heartburn associated with acid indigestion and sour stomach.

Heartburn image

Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion or sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.

Excellent safety Record

  • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets 150 mg has been taken safely with many frequently prescribed medications.
  • MAXIMUM STRENGTH Ranitidine Tablets 150 mg are sugar free.

How should I take MAXIMUM STRENGTH Ranitidine Tablets 150 mg?

  • 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.

This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours).

MAXIMUM STRENGTH Ranitidine Tablets 150 mg should not be given to children under 12 years old unless directed by a doctor.

How do MAXIMUM STRENGTH Ranitidine Tablets 150 mg work?

MAXIMUM STRENGTH Ranitidine Tablets 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

Tips for managing heartburn

  • Do not lie flat or bend over soon after eating
  • Do not eat late at night, or just before bedtime
  • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
  • Eat slowly and do not eat big meals
  • If you are overweight, lose weight
  • If you smoke, quit smoking
  • Raise the head of your bed
  • Wear loose fitting clothing around your stomach
  • Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

When should I see a doctor?

  • 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
  • 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.

Questions or comments? 1-800-719-9260

BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn. Bottle contains desiccant.

BLISTERS: Do not use if the individual blister unit is open or torn.

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010 U.S.A.

Made in India

Revision 06/08

: 04700 00 J3

Principal Display Panel

Ranitidine Tablets USP, 150 mg

Acid Reducer

Maximum Strength

Relieves and Prevents:

Heartburn Associated with Acid Indigestion & Sour Stomach

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

Compare to Zantac 150® active ingredient

Acid Reducer Carton Image 1

Acid Reducer Carton Image 1

Acid Reducer Carton Image 2

Acid Reducer Carton Image 2


ACID REDUCER  MAXIMUM STRENGTH
ranitidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-047
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
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
DIETHYL PHTHALATE  
FD&C YELLOW NO. 6  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
Product Characteristics
Color ORANGE Score no score
Shape HEXAGON (6 sided) Size 11mm
Flavor Imprint Code W;741
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-047-02 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 24 TABLET ( TABLET) in 1 BOTTLE This package is contained within the CARTON (41250-047-02)
2 NDC:41250-047-71 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 50 TABLET ( TABLET) in 1 BOTTLE This package is contained within the CARTON (41250-047-71)
3 NDC:41250-047-64 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
3 32 TABLET ( TABLET) in 1 BOTTLE This package is contained within the CARTON (41250-047-64)
4 NDC:41250-047-56 2 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
4 95 TABLET ( TABLET) in 1 BOTTLE This package is contained within the CARTON (41250-047-56)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078653 02/13/2008

Labeler - Meijer Distribution Inc (006959555)

Revised: 05/2009 Meijer Distribution Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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