FAMILY CARE STOMACH RELIEF- bismuth subsalicylate liquid 
United Exchange Corp.

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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Active ingredient (in each 30 mL dose cup)                                                       Purpose

Bismuth subsalicylate 525 mg..........................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 Reye's syndrome, a rare but serious illness.

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

Do not use if you have

Ask a doctor before use if you have

Ask a doctor before use if you are taking any drug for

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

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

FD&C Red No. 3, FD&C Red No. 40, hypromelloses, L-menthol, magnesium aluminum silicate, mint essence, polysorbate 80, propylene glycol, propylparaben, purified water, salicylic acid, sodium saccharin, sodium salicylate, sorbic acid, sucrose, xanthan gum

Distributed by:

United Exchange Corp.

Cerritos, CA 90703 USA

Made in Korea

image description

FAMILY CARE STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-626
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE1050 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MENTHOL (UNII: L7T10EIP3A)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-626-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33507/31/2015
Labeler - United Exchange Corp. (840130579)

Revised: 7/2015
Document Id: f4acd1f2-ba98-46c3-80e9-69eaffb79218
Set id: 41361b56-1d2d-4368-9bef-42686e14e477
Version: 1
Effective Time: 20150731
 
United Exchange Corp.