Label: FOSTER AND THRIVE REGULAR STRENGTH STOMACH RELIEF 527- bismuth subsalicylate 525 mg liquid

  • NDC Code(s): 70677-1191-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • ACTIVE INGREDIENT(in each 30 mL)

    Bismuth subsalicylate 525 mg


  • PURPOSE

    Upset stomach reliever and anti-diarrheal

  • USES

    relieves:


    • diarrhea
    • heartburn
    • indigestion
    • nausea
    • upset stomach associated with these symptoms
  • 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


    • allergic to salicylates (including aspirin)
    • taking other salicylate products


  • DO NOT USE IF YOU HAVE


    • an ulcer  
    • bloody or black stool   
    • 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 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(1-800-222-1222).

  • DIRECTIONS

    • shake well before use
    • mL = milliliter
    • TBSP = tablespoon
    • adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
    • do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours
    • use until diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • OTHER INFORMATION

    • each 30 mL or 2 TBSP contains:
    • potassium 25 mg
    • salicylate 260 mg
    • sodium 8 mg
    • protect from freezing
    • avoid excessive heat (over 104oF or 40oC).
    • dosage cup provided
  • 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:

    • Upset Stomach
    • Nausea
    • Heartburn
    • Indigestion
    • Diarrhea

    8 FL. OZ. (236 mL)

    F and T-527

    F and T-527

  • INGREDIENTS AND APPEARANCE
    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 DrugM00808/02/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70677-1191)
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