Label: 5 SYMPTOM DIGESTIVE RELIEF- bismuth subsalicylate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 25, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • PURPOSE

    Purpose

    Upset stomach reliever and antidiarrheal

  • INDICATIONS & USAGE

    Uses relieves

    -travelers' diarrhea
    -diarrhea
    -upset stomach due to overindulgence in food and drink, including:

    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
  • 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

    Do not use if you have

    • an ulcer
    • a bleeding problem
    • bloody or black stool
  • ASK DOCTOR

    Ask a doctor before use if you have

    • fever
    • mucus in the stool
  • ASK DOCTOR/PHARMACIST

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

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

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

  • STOP USE

    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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Directions

    • chew or dissolve in mouth
    • adults and children 12 years and over:

    -2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea

    -2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

    • do not exceed 8 doses (16 tablets) 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
  • STORAGE AND HANDLING

    Other information

    • each tablet contains: calcium 140 mg
    • salicylate 101 mg
    • low sodium
    • avoid excessive heat (over 104°F or 40°C)
  • INACTIVE INGREDIENT

    Inactive ingredients calcium carbonate, D&C red #27 lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

  • QUESTIONS

    Questions or comments? Call 1-800-910-6874

  • PRINCIPAL DISPLAY PANEL

    bismuth-48ct-ifc

  • INGREDIENTS AND APPEARANCE
    5 SYMPTOM DIGESTIVE RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-723
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    TALC (UNII: 7SEV7J4R1U)  
    MANNITOL (UNII: 3OWL53L36A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    Colorpink (Light pink to pink) Scoreno score
    ShapeROUNDSize15mm
    FlavorImprint Code 118
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-723-488 in 1 CARTON06/15/2024
    16 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00806/15/2024
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(11673-723)