FDA Label for Cvs Health Anti-diarrheal Vanilla

View Indications, Usage & Precautions

Cvs Health Anti-diarrheal Vanilla Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy,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.

Other



Drug Facts


Active Ingredient(In Each 15 Ml)



Bismuth subsalicylate 262 mg


Purposes



Antidiarrheal

Upset stomach reliever


Uses



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

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 tablespoonfuls
  • •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
    • low sodium

Inactive Ingredients



caramel, carboxymethylcellulose sodium, flavor, microcrystalline cellulose ,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



50% MORE FREE THAN THE 8 OZ NATIONAL BRAND

Cvs Health

NDC 59779-883-12

Compare to the active ingredient in Kaopectate®*

Vanilla

Anti-Diarrrheal

Bismuth Subsalicylate, 262 mg

Upset stomach reliever

  • •Effective diarrhea relief
  • •Restores natural balance
  •  Contains Salicylates

    Vanilla

  • 12 FL OZ (355 mL)

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive,Woonsocket, RI 02895

    © 2015CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-16415

    *This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate ®.


* Please review the disclaimer below.