PINK-BISMUTH - bismuth subsalicylate liquid 
Guardian Drug Company

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 Regular Strength

Active ingredient (in each 15 mL tbsp)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal


Uses

relieves:

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

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 any 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 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  immediately.

Directions

Other information

Inactive ingredients

benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Principal Display Panel

compare to the active ingredient in pepto-bismol®

Pink-Bismuth

Regular Strength

Protective coating

Bismuth subsalicylate

Anti-diarrheal/Upset stomach reliever

Soothing Relief For:

upset stomach

Indigestion

Nausea

Heartburn

Diarrhea

16 FL OZ (473 mL)

Bismuth label
PINK-BISMUTH  
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-527
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-527-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2008
2NDC:53041-527-05354 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2008
3NDC:53041-527-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2008
4NDC:53041-527-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33505/30/2008
Labeler - Guardian Drug Company (119210276)

Revised: 1/2022
Document Id: 8a8e017d-a00d-4ab4-8e16-3b472922e5e4
Set id: cb7da2b4-5e44-488b-a6e7-362e9b06c49c
Version: 4
Effective Time: 20220113
 
Guardian Drug Company