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 - 2 mg/10 mL Cup Lid Label

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

PRINCIPAL DISPLAY PANEL - 1 mg/5 mL Cup Lid Label
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II) Loperamide Hydrochloride1 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
alcohol (UNII: 3K9958V90M)  
benzoic acid (UNII: 8SKN0B0MIM)  
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sucrose (UNII: C151H8M554)  
sorbitol (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Cherry Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-106-623 in 1 CASE
110 in 1 TRAY
1NDC:68094-106-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07324309/01/200907/31/2014
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-217
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II) Loperamide Hydrochloride2 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
alcohol (UNII: 3K9958V90M)  
benzoic acid (UNII: 8SKN0B0MIM)  
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sucrose (UNII: C151H8M554)  
sorbitol (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Cherry Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-217-623 in 1 CASE
110 in 1 TRAY
1NDC:68094-217-5910 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07324308/18/200906/30/2014
Labeler - Precision Dose Inc. (035886746)

Revised: 1/2016
Document Id: cc200dd0-d975-4ee0-8d03-71915f58fc8a
Set id: 7e51dc28-4f25-4558-af7c-46d4806e137b
Version: 3
Effective Time: 20160127
 
Precision Dose Inc.