Loperamide Hydrochloride

Precision Dose Inc.

LOPERAMIDE HYDROCHLORIDE ORAL SOLUTION

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL)
• Purpose
• Use
• Warnings
  • When using this product
• Directions
• Loperamide Hydrochloride Other information
• Inactive ingredients
• How Supplied
• PRINCIPAL DISPLAY PANEL - 2 mg/10 mL Cup Lid Label
• PRINCIPAL DISPLAY PANEL - 1 mg/5 mL Cup Lid Label

FULL PRESCRIBING INFORMATION

1 mg/5 mL
2 mg/10 mL

Cherry Mint Flavor

For Hospital Use Only

Drug Facts

Active ingredient (in each 5 mL)

Loperamide HCl 1 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

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 last 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

use as directed per healthcare professional

Loperamide Hydrochloride Other information

• contains 0.5% alcohol
• store between 20° - 25°C (68° - 77°F)
• see individual label or shipper label for lot number and expiration date

Inactive ingredients

alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

How Supplied

NDC 68094-106-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-217-62
10 mL per unit dose cup
Thirty (30) cups per shipper

Distributed By:
Perrigo Company
515 Eastern Avenue
Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
S. Beloit, IL 61080

LI753
Rev. 05/09

PRINCIPAL DISPLAY PANEL - 2 mg/10 mL Cup Lid Label

NDC 68094-217-59

PrecisionDose™

LOPERAMIDE Hydrochloride
Oral Solution
2 mg/10 mL

Delivers 10 mL Contains 0.5% Alcohol
Each 5 mL contains 1 mg Loperamide HCl

Store at 20°-25° (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 1 mg/5 mL Cup Lid Label

NDC 68094-106-59

PrecisionDose™

LOPERAMIDE Hydrochloride
Oral Solution
1 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 6180