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  5. Label Information: Welmate Anti Diarrheal Loperamide Hcl Softgels

FDA Label for Welmate Anti Diarrheal Loperamide Hcl Softgels

View Indications, Usage & Precautions

Table of Contents

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

Welmate Anti Diarrheal Loperamide Hcl Softgels Product Label

The following document was submitted to the FDA by the labeler of this product Yyba 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 Softgel)



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
  • in children under 12 years of age

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 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 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 (1-800-222-1222) right away.


Directions



  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • not for use in children under 12 years of age
  • adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other Information



  • do not use if blister unit is torn or open
  • store at 20°- 25°C (68° - 77°F)

Inactive Ingredients



butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.


Questions?



call toll-free 1-800-935-6737


Package Labeling:



Label2 - Label2

Label2 - Label2


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