BISMUTH SUBSALICYLATE- bismuth subsalicylate liquid 
Lohxa

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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Bismuth Subsalicylate

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

PRINCIPAL DISPLAY

BISMUTH SUBSALICYLATE 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70166-059(NDC:0904-1313)
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:70166-059-0150 in 1 CARTON12/03/201811/20/2020
115 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33505/30/2008
Labeler - Lohxa (079872715)

Revised: 2/2021
Document Id: bc2e4ee1-fc9c-7046-e053-2995a90a4d2e
Set id: c99c1061-baa4-4c0f-bbae-3d1eea43a6a5
Version: 2
Effective Time: 20210225
 
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