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  5. Label Information: Kao-bis

FDA Label for Kao-bis

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. OTHER INFORMATION
    15. PRINCIPAL DISPLAY PANEL

Kao-bis 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



Anti-diarrheal/upset stomach reliever


Uses



  • relieves diarrhea
  • relieves nausea and upset stomach associated with this symptom

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 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



    shake well before each use
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • 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 (30 mL)
  • 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


Other Information



  • Store at room temperature. Protect from freezing and excessive heat (over 40oC or 104oF)
  • each tablespoon (15 mL) contains: magnesium 32 mg
  • each tablespoon (15 mL) contains: total salicylate 159 mg
  • each tablespoon (15 mL) contains: sodium 24 mg
  • TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Principal Display Panel



Bismuth label - m527

Bismuth label - m527


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