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  5. Label Information: Qc Quality Choice Pink Bismuth Stomach Relief

FDA Label for Qc Quality Choice Pink Bismuth Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT(IN EACH 15 ML TABLESPOON)
    3. PURPOSES
    4. USES
    5. REYE'S SYNDROME:
    6. ALLERGY ALERT: CONTAINS SALICYLATE. DO NOT TAKE IF YOU ARE
    7. OTC - DO NOT USE
    8. OTC - ASK DOCTOR
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. OTC - STOP USE
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. PRINCIPAL DISPLAY PANEL - 236 ML BOTTLE LABEL

Qc Quality Choice Pink Bismuth Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Manufacturing Assn. 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.

Other



Drug Facts


Active Ingredient(In Each 15 Ml Tablespoon)



Bismuth subsalicylate 262 mg


Purposes



Upset stomach reliever and antidiarrheal


Uses



relieves

  • •travelers’diarrhea
  • •diarrhea
  • •upset stomach due to overindulgence in food and drink, including:
  • •heartburn
  • •indigestion
  • •upset stomach
  • •nausea
  • •gas
  • •belching

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

Otc - Do Not Use



Do not use if you have

  • •an ulcer
  • •a bleeding problem
  • •bloody or black stool

Otc - Ask Doctor



Ask a doctor before use if you have

  • •fever
  • •mucus in the stool

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking any drug for

  • •anticoagulation (thinning the blood)
  • •diabetes
  • •gout
  • •arthritis

Otc - When Using



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


Otc - Stop Use



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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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 (2 tbsp or 30 ml) every ½ 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 tbsp contains: sodium 6 mg
    • •low sodium
    • •sugar free
    • • salicylate 130 mg
    • •protect from freezing
    • •avoid excessive heat (more than 104°F or 40°C)
    • •TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken.

Inactive Ingredients



carboxymethylcellulose sodium, flavor, microcrystalline cellulose, potassium hydroxide ,potassium sorbate, purified water, red 22,red 28, salicylic acid, simethicone emulsion, sodium benzoate ,sucralose, xanthan gum


Principal Display Panel - 236 Ml Bottle Label



QC

Quality Choice®

NDC 63868-303-08

*Compare to the active ingredient in PEPTO-BISMOL® Regular strength

PINK BISMUTH

Stomach Relief

Bismuth Subsalicylate 262mg

Soothing Relief from:

* Please review the disclaimer below.