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Pink Bismuth Maximum Strength

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 525mg in 15mL
Labeler: Rij Pharmaceutical Corporation
NDC Code: 53807-192

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.

Drug Facts

Active ingredient (in each tablespoon= 15 mL)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and anti-diarrheal

Uses
  • relieves upset stomach due to overindulgence in food or drink
  • controls diarrhea

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from children 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
  • if you have an ulcer or bleeding problem

Ask a doctor before use if you have
  • fever
  • mucus in the stool
  • a magnesium-restricted diet
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

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 4 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
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • shake well before using
  • use pre-measured cup for accurate dosing
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 4 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults & children 12 years and over: 2 tablespoons
  • children under 12 years: ask a doctor

Inactive ingredients

Carboxymethylcellulose sodium, D&C Red #3, FD&C Red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium saliycylate, sorbitol, water

Other information
  • Store at room temperature. Protect from freezing and excessive heat (over 40oF or 104oC)
  • each tablespoon (15 mL) contains: magnesium 32 mg
  • each tablespoon (15 mL) contains: sodium 24 mg
  • each tablespoon (15 mL) contains: total salycylate 262 mg
  • TAMPER EVIDENT: DO NOT USE IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING.

Principal Display Panel

PINK BISMUTH MAXIMUM STRENGTH 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-192
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
FD&C RED NO. 3 
FD&C RED NO. 40 
GLYCERIN 
MAGNESIUM ALUMINUM SILICATE 
SACCHARIN SODIUM 
SALICYLIC ACID 
SODIUM BENZOATE 
SODIUM SALICYLATE 
SORBITOL 
WATER 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53807-192-08237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33503/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)

Revised: 04/2013
 
Rij Pharmaceutical Corporation

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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