Label: THREDA- bismuth subsalicylate liquid

  • NDC Code(s): 53145-057-04
  • Packager: Menper Distributors, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/13

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  • ACTIVE INGREDIENT

    Active Ingredient (in each 15 mL tablespoon)
    Bismuth Subsalycilate 262 mg

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  • PURPOSE

    Purpose
    upset stomach reliever and antidiarrheal

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  • INDICATIONS & USAGE

    Uses

    Relieves:

    • Heartburn
    • Indigestion
    • Upset Stomach
    • Nausea
    • Diarrhea
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  • WARNINGS

    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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

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  • DO NOT USE

    Allergy Alert: Contains salicylate. Do not take if you are:
    Allergic to salicilates (including aspirin) Taking other salicylate products

    Do not use if you have:

    • An ulcer
    • A bleeding problem
    • Bloody or black stool

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  • ASK DOCTOR

    Ask a doctor before useifyou have

    • Fever
    • Mucus in the stool
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  • ASK DOCTOR/PHARMACIST

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

    • Anticoagulation (thinning the blood)
    • Diabetes
    • Gout
    • Arthritis
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  • WHEN USING

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

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  • STOP USE

    Stop use and ask a doctor if:

    • Symptoms get worse
    • Ringing in the ears or loss of hearing occurs
    • Diarrhea lasts more than 2 days
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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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  • DOSAGE & ADMINISTRATION

    Directions:
    Shake well before use
    Adult and children 12 years and over: 1 dose (2tbsp or 30 mL) every 1/2 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 water or clear fluids to help prevent dehydration caused by diarrhea.

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  • OTHER SAFETY INFORMATION

    Other Information
    Each tablespoon contains: Sodium 6 mg, Low sodium, Sugar free, Salicylate 130 mg. Protect from freezing. Avoid excessive heat (more than 140°F or 40°C)

    Tamper-Evident: Do not use if imprinted shrinkband is missing or broken

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  • INACTIVE INGREDIENT

    Inactive ingredients

    BENZOIC ACID, MAGNESIUM ALUMINUM SILICATE, METHYLCELLULOSE (100 CPS), D&C RED NO. 22, D&C RED NO. 28, SALICYLIC ACID, SODIUM SALICYLATE, SORBIC ACID, SUCRALOSE, WATER

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  • INGREDIENTS AND APPEARANCE
    THREDA 
    bismuth subsalycilate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53145-057
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    MAGNESIUM ALUMINUM SILICATE  
    METHYLCELLULOSE (100 CPS)  
    D&C RED NO. 22  
    D&C RED NO. 28  
    SODIUM SALICYLATE  
    SORBIC ACID  
    SUCRALOSE  
    SALICYLIC ACID  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53145-057-04 1 in 1 CARTON
    1 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part335 02/21/2012
    Labeler - Menper Distributors, Inc. (101947166)
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