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  5. Label Information: Pink Bismuth

FDA Label for Pink Bismuth

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 15 ML TABLESPOON)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. REYE'S SYNDROME:
    6. ALLERGY ALERT:
    7. DO NOT USE IF
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK A DOCTOR IF
    12. IF PREGNANT OR BREAST-FEEDING,
    13. KEEP OUT OF REACH OF CHILDREN.
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. PACKAGE LABEL

Pink Bismuth Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, Inc.. 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 15 Ml Tablespoon)



Bismuth subsalicylate 262 mg


Purpose



Upset stomach reliever and antidiarrheal


Uses



relieves

  • heartburn
  • indigestion
  • upset stomach
  • nausea
  • diarrhea

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 and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes 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
  • 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 use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (2Tbsp or 30 ml) every 1/2 to 1 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 clear fluids to help prevent dehydration caused by diarrhea

Other Information



  • each Tspb contains: sodium 9 mg
  • salicylate 130 mg
  • protect from freezing
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)
  • sugar free
  • TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.

Inactive Ingredients



propylene glycol, sodium benzoate, flavor, magnesium aluminum silicate, methylcellulose, red 40, saccharin sodium, salicylic acid, sodium slicylate, sorbic acid, water, sucrose, xanthan gum


Package Label



Pink Bismuth

image of bottle label - pinkbismuth.carton

image of bottle label - pinkbismuth.carton


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