PINK BISMUTH- bismuth subsalicylate tablet, chewable 
Qualitest Pharmaceuticals

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.

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Pink Bismuth

Active ingredient (in each tablet)

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

Purpose

Antidiarrheal/Antacid

Uses

  • controls diarrhea
  • relieves heartburn, indigestion, nausea and upset stomach

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 use if you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if

you are taking a drug for

  • anticoagulation (thinning of 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 for 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 (1-800-222-1222) immediately.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed
    • do not exceed 16 tablets in 24 hours
    • use until diarrhea stops but no more than 2 days
  • Children under 12 years of age: 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  15°– 30°C (59°– 86°F)
  • do not use if cellophane unit is torn

Inactive ingredients

acacia gum, aspartame, calcium carbonate, D&C red # 27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Principal Display Panel

Qualitest Pink Bismuth

Qualitest Pink Bismuth

 

PINK BISMUTH 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0235
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DEXTRATES (UNII: G263MI44RU)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize15mm
FlavorImprint Code RH046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0235-161 in 1 CARTON04/28/200311/26/2018
130 in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33504/28/200311/26/2018
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Allegiant Health079501930ANALYSIS(0603-0235) , LABEL(0603-0235) , MANUFACTURE(0603-0235) , PACK(0603-0235)

Revised: 11/2018
 
Qualitest Pharmaceuticals