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Pink Bismuth by Qualitest Pharmaceuticals

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0235

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pink Bismuth Tablets

ACTIVE INGREDIENTS (IN EACH TABLET)

Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

PURPOSE

Antidiarrheal/Antacid

USES
  • controls diarrhea
  • relieves heartburn, indigestion, nausea and upset stomach without constipating

WARNINGS

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do not use if you have
  • bloody or black stool
  • an ulcer
  • a bleeding problem

Ask a doctor before if you have
  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you taking any drug for
  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product

a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

DIRECTIONS
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Adults and Children 12 years and over: 525mg (2 tablets) every ½ to 1 hour or 1050mg (4 tablets) every hour as needed
  • do not exceed 4200mg (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12 years: ask a doctor

OTHER INFORMATION
  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • Calcium content per tablet: 73mg
  • save carton for full directions and warnings
  • store at room temperature 59°-86°F (15°-30°C)
  • do not use if cellophane unit is torn

INACTIVE INGREDIENTS

Aspartame, calcium carbonate, D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide.

PRINCIPAL DISPLAY PANEL

Product Label

  • Fast Acting
  • Soothing Coating Action
  • Provides relief for indigestion, upset stomach, heartburn, diarrhea and nausea

Made in USA for

Qualitest Pharmaceuticals, Inc.

Huntsville, AL 35811, USA

PINK BISMUTH  
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0235
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CALCIUM CARBONATE 
D&C RED NO. 27 
DEXTRATES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize15mm
FlavorImprint CodeRH046
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0235-1630 TABLET, CHEWABLE (TABLET) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33504/28/2003
Labeler - Qualitest Pharmaceuticals (011103059)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705manufacture(0603-0235), label(0603-0235)

Revised: 09/2012
 
Qualitest Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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