LOPERAMIDE HYDROCHLORIDE - loperamide hydrochloride solution 
Precision Dose Inc.

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LOPERAMIDE HYDROCHLORIDE ORAL SOLUTION

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

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

LOPERAMIDE HYDROCHLORIDE  loperamide hydrochloride   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68094-106 (0113-0377) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Loperamide Hydrochloride (Loperamide) Loperamide Hydrochloride 1 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength alcohol   benzoic acid   citric acid monohydrate   glycerin   propylene glycol   sodium benzoate   water   sorbitol   sucrose

Product Characteristics Color      Score      Shape Size Flavor MINT (Cherry Mint) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68094-106-62 3 TRAY In 1 CASE contains a TRAY 1 10 CUP In 1 TRAY This package is contained within the CASE (68094-106-62) and contains a CUP, UNIT-DOSE (68094-106-59) 1 68094-106-59 5 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-106-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073243	09/01/2009

LOPERAMIDE HYDROCHLORIDE  loperamide hydrochloride   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68094-217 (0113-0377) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Loperamide Hydrochloride (Loperamide) Loperamide Hydrochloride 2 mg  in 10 mL

Inactive Ingredients Ingredient Name Strength alcohol   benzoic acid   citric acid monohydrate   glycerin   propylene glycol   sodium benzoate   water   sorbitol   sucrose

Product Characteristics Color      Score      Shape Size Flavor MINT (Cherry Mint) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68094-217-62 3 TRAY In 1 CASE contains a TRAY 1 10 CUP In 1 TRAY This package is contained within the CASE (68094-217-62) and contains a CUP, UNIT-DOSE (68094-217-59) 1 68094-217-59 10 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-217-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073243	08/18/2009

Labeler - Precision Dose Inc. (035886746)

Revised: 01/2011Precision Dose Inc.