Anti-Diarrheal Loperamide HCl

TOP CARE (Topco Associates LLC)
P and L Development of New York Corporation

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each capsule)
• Purpose
• Use
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Anti-Diarrheal Loperamide HCl Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel
• Product Label

FULL PRESCRIBING INFORMATION

Active ingredient (in each capsule)

Loperamide HCI 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

Do not use

• if you have bloody or black stool
• in children under 12 years of age (see Other information)

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
• 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

Anti-Diarrheal Loperamide HCl Other information

• do not use if carton or blister unit is open or torn
• store at 20º-25ºC (68º-77ºF)
• avoid excessive heat above 40°C (104°F)
• see side panel for lot number and expiration date
• use the 1 mg soft gelatin capsule product for children 6 to under 12 years of age

Inactive ingredients

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

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

CONTROLS THE SYMPTOMS OF DIARRHEA

Anti-Diarrheal Loperamide HCl

SOFT GELATIN CAPSULES, 2 mg

• Suitable for adults and children 12 years and over

COMPARE TO IMODIUM® A-D active ingredient**

SOFTGELS*

*each liquid-filled capsule contains 2 mg Loperamide HCl

**This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, owner of the registered trademark of Imodium® A-D.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

THIS PRODUCT IS PACKAGING IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Product Label