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  5. Label Information: Bismuth

FDA Label for Bismuth

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. REYE’S SYNDROME
    5. ALLERGY ALERT
    6. DO NOT USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU
    9. STOP USE AND ASK A DOCTOR IF
    10. WHEN USING THIS PRODUCT
    11. IF PREGNANT OR BREAST-FEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. INACTIVE INGREDIENTS

Bismuth Product Label

The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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.

Active Ingredient



Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)


Purpose



Antidiarrheal/Antacid


Uses



controls diarrhea relieves heartburn, indigestion, nausea and upset stomach without constipating


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



bloody or black stool an ulcer 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 the blood) diabetes gout arthritis


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


When Using This Product



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


If Pregnant Or Breast-Feeding



ask a health professional before use.


Keep Out Of Reach Of Children



In case of accidental overdose, contact a doctor or Poison Control Center immediately.


Directions



drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Adults and Children 12 years and over: 525 mg ( 2 tablets) every ½ to 1 hour or 1050 mg (4 tablets) every hour as needed do not exceed 4200 mg ( 16 tablets) in 24 hours use until diarrhea stops but not more than 2 days
Children under 12 years: ask a doctor


Inactive Ingredients



aspartame, calcium carbonate, , D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide


* Please review the disclaimer below.