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  5. Label Information: Flanadol Pronto Bismuth

FDA Label for Flanadol Pronto Bismuth

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH 15ML TABLESPOONFUL = TBSP)
    3. PURPOSES
    4. WARNINGS
    5. OTHER INFORMATION
    6. PACKAGING

Flanadol Pronto Bismuth Product Label

The following document was submitted to the FDA by the labeler of this product Jomex International Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredient (In Each 15Ml Tablespoonful = Tbsp)



Bismuth Subsalicylate 262 mg


Purposes



Upset stomach reliever and antidiarrheal


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 behaviour 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  • a bleeding problem  • bloody or black stool

    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 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 a doctor if  • symptoms get worse or last more than 2 days  • diarrhea lasts more than 2 days  • ringing in the ears or loss of hearing occurs

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


Other Information



• each 15 mL tablespoonful contains: sodium 6 mg

• salicylate 130 mg  • protect from freezing  • low sodium • sugar free

• avoid excessive heat (over 104°F or 40°C)

• visit www.info-xtra.com for health information

• TAMPER EVIDENT: Do not use if imprinted neckband is missing or broken


Packaging




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