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  5. Label Information: Qc Anti Diarrheal Vanilla Regular Flavor

FDA Label for Qc Anti Diarrheal Vanilla Regular Flavor

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (PER 15 ML)
    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. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL - 355 ML BOTTLE LABEL

Qc Anti Diarrheal Vanilla Regular Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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 (Per 15 Ml)



Bismuth subsalicylate 262 mg


Purposes



Antidiarrheal/Upset stomach reliever


Uses



Relieves

  • ▪traveler’s diarrhea
  • ▪diarrhea
  • ▪upset stomach due to overindulgence in food and drink
  • ▪heartburn
  • ▪indigestion
  • ▪nausea
  • ▪gas

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

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

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 at 1-800-222-1222.


Directions



  • ▪shake well immediately before each use
  • ▪adults and children 12 years of age and older : 30 ml or 2 tablespoonful
  • ▪for accurate dosing, use convenient pre-measured dose cup
  • ▪repeat dose every 1/2 hour to 1 hour as needed
  • ▪do not exceed 8 doses 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 15mL tablespoon contains: sodium 10 mg
  • ▪each 15mL tablespoon contains: salicylate 130 mg
  • ▪do not use if printed inner seal is broken or missing
  • ▪store at room temperature

Inactive Ingredients



caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum


Questions Or Comments?



1-866-467-2748


Principal Display Panel - 355 Ml Bottle Label



NDC 63868-339-12

Compare to the active ingredient in Kaopectate®

Diarrhea Relief

Bismuth Subsalicylate, 262 mg

Bismuth Subsalicylate, 262 mg

Antidiarrheal

Upset Stomach Reliever

Effective Diarrhea Relief

Restores Natural Balance

* Please review the disclaimer below.