PINK BISMUTH - bismuth subsalicylate liquid 
Kareway Product, Inc.

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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Drug Facts

Active ingredient (in each 15 ml Tablespoon)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

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 Reyes 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

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

  • fever
  • mucus in the stool

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 2 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

Other information

Inactive ingredients

propylene glycol, sodium benzoate, flavor, magnesium aluminum silicate, methylcellulose, red 40, saccharin sodium, salicylic acid, sodium slicylate, sorbic acid, water, sucrose, xanthan gum

Package label

Pink Bismuthimage of bottle label

PINK BISMUTH 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0505
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0505-4120 mL in 1 BOTTLE
2NDC:67510-0505-6177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33508/29/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 8/2011
Document Id: 1a79d259-9965-4ace-ad33-2bc01ba8f2ec
Set id: cdc53b63-b013-4f89-844e-db95b06ba41b
Version: 1
Effective Time: 20110829
 
Kareway Product, Inc.