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  5. Label Information: Anti Diarrheal

FDA Label for Anti Diarrheal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    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?

Anti Diarrheal Product Label

The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. 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 5 Ml)



Loperamide HCl 1 mg


Purpose



Anti-diarrheal


Uses



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.


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.
  • only use attached measuring cup to dose product
    • adults and children 12 years and over4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours
    children 9-11 years (60-95 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 6 teaspoonfuls in 24 hours
    children 6-8 years (48-59 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 4 teaspoonfuls in 24 hours
    children under 6 years (up to 47 lbs)ask a doctor

Other Information



  • do not use if carton is opened or if printed plastic neckband is broken or missing
  • store between 20°-25°C (68°-77°F)
  • see bottom panel for lot number and expiration date

Inactive Ingredients



alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose


Questions Or Comments?



1-800-719-9260


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