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  5. Label Information: Handy Solutions Anti-diarrheal

FDA Label for Handy Solutions Anti-diarrheal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    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 YOU ARE PREGNANT OR BREAST FEEDING,
    11. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE LABELING:

Handy Solutions Anti-diarrheal Product Label

The following document was submitted to the FDA by the labeler of this product Navajo Manufacturing Company 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.

Active Ingredient (In Each Caplet)



Loperamide Hydrochloride 2 mg


Purpose



Antidiarrheal


Uses



Controls the symptoms of diarrhea, including Traveler’s 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 stools


Ask A Doctor Before Use If You Have



• a fever
• mucus in 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 more than 2 days
• you get abdominal swelling or bulging. These may be signs of a serious condition.


If You Are Pregnant Or Breast Feeding,



ask a health professional before use.


Keep This And All Drugs Out Of The Reach Of Children.



In case of accidental overdose, contact a physician or Poison Control Center right away.


Directions



do not use more than directed
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

 Adults and children (12 years and older): Take 2 caplets after the first
loose bowel movement
followed by 1 caplet after each
subsequent loose bowel
movement but no more than
4 caplets in 24 hours.
 Children under 12 years: Do not give to children under
12 years of age.


Other Information



• store between 68° - 77°F (20° - 25°C)
• tamper-evident sealed packets
• do not use any opened or torn packet


Inactive Ingredients



anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow # 10, FD&C blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch


Questions Or Comments?



1-800-525-5097


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