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  5. Label Information: Bismuth

FDA Label for Bismuth

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLESPOON= 15 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. INACTIVE INGREDIENTS
    14. STORAGE AND HANDLING
    15. PRINCIPAL DISPLAY PANEL

Bismuth Product Label

The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical Corporation. 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 (In Each Tablespoon= 15 Ml)



Bismuth subsalicylate 262 mg


Purpose



Upset stomach reliever and anti-diarrheal


Uses



  • relieves upset stomach due to overindulgence in food or drink
  • controls diarrhea

Warnings



Reye's syndrome: Children and teenagers who have or are recovering from children 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
  • if you have an ulcer or bleeding problem

Ask A Doctor Before Use If You Have



  • fever
  • mucus in the stool
  • a magnesium-restricted diet
  • a sodium-restricted diet

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 A 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  right away.


Directions



  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • shake well before using
  • use pre-measured cup for accurate dosing
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults & children 12 years and over: 2 tablespoons
  • children under 12 years: ask a doctor

Inactive Ingredients



Carboxymethylcellulose sodium, D&C Red #3, FD&C Red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium saliycylate, sorbitol, water


Storage And Handling



  • Store at room temperature. Protect from freezing and excessive heat (over 40oF or 104oC)
  • each tablespoon (15 mL) contains: magnesium 32 mg
  • each tablespoon (15 mL) contains: sodium 24 mg
  • each tablespoon (15 mL) contains: total salycylate 159 mg
  • TAMPER EVIDENT:Do not use if printed inner cap seal is broken or missing..

Principal Display Panel



Bismuth label - m527

Bismuth label - m527


* Please review the disclaimer below.