FOSTER AND THRIVE REGULAR STRENGTH STOMACH RELIEF 527 - bismuth subsalicylate 525 mg liquid 
Strategic Sourcing Services 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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Foster and Thrive Regular Strength Stomach Relief -527 

ACTIVE INGREDIENT(in each 30 mL)

Bismuth subsalicylate 525 mg


PURPOSE

Upset stomach reliever and anti-diarrheal

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 OR PHARMACIST 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 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 immediately(1-800-222-1222).

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

benzoic acid, D&C red # 22, D&C red  #28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

QUESTIONS OR COMMENTS?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

































PRINCIPAL DISPLAY PANEL

NDC 70677-1191-1

COMPARE TO PEPTO-BIMOL® ACTIVE INGREDIENT*

Foster and Thrive TM

REGULAR STRENGTH

Stomach Relief

Bismuth Subsalicylate 525mg

ANTIDIARRHEAL UPSET STOMACH RELIEVER

Relieves:

8 FL. OZ. (236 mL)


F and T-527


FOSTER AND THRIVE REGULAR STRENGTH STOMACH RELIEF 527 
bismuth subsalicylate 525 mg liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1191
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) 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)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-1191-1236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33508/02/2023
Labeler - Strategic Sourcing Services LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70677-1191)

Revised: 8/2023
Document Id: f204f9ab-645b-4656-93a1-90aa4c369922
Set id: f204f9ab-645b-4656-93a1-90aa4c369922
Version: 1
Effective Time: 20230802
 
Strategic Sourcing Services LLC