Your browser does not support JavaScript! MAXIMUM STRENGTH HEARTBURN RELIEF (RANITIDINE) TABLET [GREENBRIER INTERNATIONAL, INC.]
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MAXIMUM STRENGTH HEARTBURN RELIEF (ranitidine) tablet
[GREENBRIER INTERNATIONAL, INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each tablet)

Ranitidine 150 mg
(as ranitidine hydrochloride USP, 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 any 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 wheeing, 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.
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • heartburn with lightheadedness, sweating, or dizziness 

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 (1-800-222-1222) 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

  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
  • store at 20º-25ºC (68º-77ºF)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free
  • see end flap for expiration date and lot number 

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hyrpomellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide 

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF MAXIMUM STRENGTH ZANTAC 150®*

MAXIMUM STRENGTH
HEARTBURN
RELIEF
• Ranitidine 150 mg
- Acid Reducer

Relieves and prevents heartburn due to acid indigestion

30 tablets

DOES NOT CONTAIN GLUTEN
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Zantac 150®.
50844    ORG031362001
Product of India

ITEM #200907
Distributed by: Greenbrier International, Inc.
Chesapeake, VA 23320 USA

TAMPER EVIDENT: DO NOT USE IF CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN

Assured 44-620

Assured 44-620

MAXIMUM STRENGTH HEARTBURN RELIEF 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-0620
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize12mm
FlavorImprint Code 9R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0620-11 in 1 CARTON
130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20053606/15/2013
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Revised: 3/2014
 
GREENBRIER INTERNATIONAL, INC.

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