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  5. Label Information: Careone Diarrhea Control

FDA Label for Careone Diarrhea Control

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 7.5 ML)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE IF YOU HAVE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Careone Diarrhea Control Product Label

The following document was submitted to the FDA by the labeler of this product American Sales Company. 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 7.5 Ml)



Loperamide HCl 1 mg


Purpose



Anti-diarrheal


Use



controls symptoms of diarrhea, including Travelers’ Diarrhea


Warnings



Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl


Do Not Use If You Have



bloody or black stool


Ask A Doctor Before Use If You Have



  • •fever
  • •mucus in the stool
  • •a history of liver disease

Ask A Doctor Or Pharmacist Before Use If You Are



taking antibiotics


When Using This Product



  • •tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop Use And Ask A Doctor If



  • •symptoms get worse
  • •diarrhea lasts for more than 2 days
  • •you get abdominal swelling or bulging. These may be signs of a serious condition.

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. (1-800-222-1222)


Directions



  • •drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • •find right dose on chart. If possible, use weight to dose; otherwise use age.
  • •shake well before using
  • •only use attached measuring cup to dose product

    • adults and children 12 years and over

    30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours

    children 9-11 years (60-95 lbs)

    15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours

    children 6-8 years (48-59 lbs)

    15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours

    children under 6 years (up to 47 lbs)

    ask a doctor


Other Information



  • •each 30 mL (6 tsp) contains: sodium 15 mg
  • •store between 20-25°C (68-77°F)
  • •see side panel for lot number and expiration date

Inactive Ingredients



anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to the active ingredient in Imodium® A-D Anti-Diarrheal Liquid

For Ages 6 Years And Up

DIARRHEA CONTROL

Loperamide Hydrochloride Oral Suspension

Anti Diarrheal

Controls the symptoms of diarrhea

Mint Flavor

1mg Loperamide Hydrochloride per 7.5mL

4 FL OZ (120mL)


* Please review the disclaimer below.