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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 CAPLET)
    2. PURPOSE
    3. USE
    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?
    16. PRINCIPAL DISPLAY PANEL

Anti Diarrheal Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen 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 Caplet)



Loperamide HCl 2 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

Heart alert: Taking more than directed can cause serious heart problems or death


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
  • •a history of abnormal heart rhythm

Ask A Doctor Or Pharmacist Before Use If You Are



taking a prescription drug. Loperamide may interact with certain prescription drugs.


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.

    • adults and children

    12 years and over

    2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours

    children 9-11 years

    (60-95 lbs)

    1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours

    children 6-8 years

    (48-59 lbs)

    1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours

    children 2-5 years

    (34 to 47 lbs)

    ask a doctor

    children under 2 years

    (up to 33 lbs)

    do not use


Other Information



  • •store at 20°-25°C (68°-77°F)
  • •see end panel for lot number and expiration date

Inactive Ingredients



anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to Imodium® A-D active ingredient

Anti-Diarrheal

LOPERAMIDE HYDROCHLORIDE TABLETS, 2 mg

ANTI-DIARRHEAL

CAPLETS

-Controls the symptoms of diarrhea

12 CAPLETS*

[*CAPSULE-SHAPED TABLETS]

ACTUAL SIZE

SEE NEW WARNINGS

224-94-anti-diarrheal - image 01

224-94-anti-diarrheal - image 01


* Please review the disclaimer below.