STOMACH RELIEF- bismuth subsalicylate liquid 
PAI Holdings, LLC

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 30 mL dose )

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/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 Reye's syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are:

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

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)

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 or last more than 2 days
  • 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 childen.

In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

Directions

Other information

NDC 0121-0910-30: 30 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum

Questions or comments?

Call 1-800-845-8210.

PACKAGED BY:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R11/20

Principal Display Panel

Delivers 30 mL

NDC 0121-0910-30

Bismuth Subsalicylate

525 mg/30 mL

Upset stomach reliever/Antidiarrheal

Package Not Child-Resistant

Pkg by: Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT

15 mL - Unit Dose Cup

STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0910
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0910-404 in 1 CASE07/17/2020
110 in 1 TRAY
1NDC:0121-0910-3030 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 finalpart33507/17/2020
Labeler - PAI Holdings, LLC (044940096)
Establishment
NameAddressID/FEIBusiness Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693label(0121-0910) , manufacture(0121-0910)

Revised: 7/2023
Document Id: bf4391f3-878b-46e1-ae72-9c03e9f605dd
Set id: dacfae86-ac70-4dff-8211-6c9a0596bee6
Version: 4
Effective Time: 20230707
 
PAI Holdings, LLC