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  5. Label Information: Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal

FDA Label for Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. REYE’S SYNDROME:
    5. DO NOT TAKE IF YOU ARE
    6. DO NOT USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING ANY DRUG FOR
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING,
    12. KEEP OUT OF REACH OF CHILDREN.
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS

Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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



(per 15mL):

Bismuth subsalicylate 262 mg


Purpose



Anti-diarrheal

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.


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



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

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 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 15 mL tablespoonful contains: sodium 4 mg
  •  each 15 mL tablespoonful contains: total salicylates 130 mg
  •  do not use if inner seal is broken or missing
  •  low sodium

Inactive Ingredients



caramel, carboxymethylcellulose sodium, flavor, microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum (245-241)

Dist. by CHATTEM, INC.

P.O. Box 2219

Chattanooga, TN 37409 USA

© 2008 Chattem, Inc.

Made in Canada

CHATTEM® www.chattem.com 


* Please review the disclaimer below.