Anti-Diarrheal

Care One (American Sales Company)
P and L Development of New York Corporation

Loperamide HCl 2 mg

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 doctor if
• If pregnant or breast-feeding,
• Keep out of reach of children
• Directions
• Anti-Diarrheal 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 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 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 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 of age 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 Other information

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

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

Inactive Ingredients

Questions or comments?

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN IMODIUM® A-D **

Anti-Diarrheal

Soft Gelatin Capsules, 2 mg

Loperamide HCl

Controls the symptoms of diarrhea

Suitable for adults and children 12 years and over

LIQUID- FILLED SOFTGELS*

*each liquid-capsule contains 2 mg Loperamide HCl

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: American Sales Company

4201 walden ave, Lancaster, NY 14086

Manufactured by: Banner Pharmacaps Inc.

4125 Premier drive, High point, NC 27265

Product Label