LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride solution 
Precision Dose, Inc.

----------

Loperamide Hydrochloride

Mint Flavor

1 mg/7.5 mL 2 mg/15 mL

For Hospital Use Only

Drug Facts

Active ingredient (in each 7.5 mL)

Loperamide HCl 1 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Read complete directions and warnings before using.

Warnings

Allergy alert

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Heart alert

Taking more than directed can cause serious heart problems or death

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 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. (1-800-222-1222)

Directions

  • Use as directed per healthcare professional.
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • shake well before using
  • mL = milliliter
adults and children 12 years and over30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
children 9-11 years (60-95 lbs)15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
children 6-8 years (48-59 lbs)15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours
children 2-5 years (34 to 47 lbs)ask a doctor
children under 2 years (up to 33 lbs)do not use

Other information

  • each 30 mL contains: sodium 15 mg
  • store between 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Gluten Free

How Supplied

NDC 68094-029-62
7.5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-129-62
15 mL per unit dose cup
Thirty (30) cups per shipper

Distributed By
Perrigo Company
Allegan, MI 49010

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1251 Rev. 04/22

PRINCIPAL DISPLAY PANEL - 1 mg/7.5 mL Cup Lid Label

NDC 68094-029-59

PrecisionDose™

LOPERAMIDE Hydrochloride
Oral SOLUTION
1 mg/7.5 mL

Shake Well Delivers 7.5 mL Gluten Free
Contains 3.75 mg Sodium Hospital Use Only

Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1252 R1

PRINCIPAL DISPLAY PANEL - 1 mg/7.5 mL Cup Lid Label
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-029(NDC:0113-1645)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II) Loperamide Hydrochloride1 mg  in 7.5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
carboxymethylcellulose sodium, unspecified (UNII: K679OBS311)  
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Glycerin (UNII: PDC6A3C0OX)  
Microcrystalline cellulose (UNII: OP1R32D61U)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sucralose (UNII: 96K6UQ3ZD4)  
titanium dioxide (UNII: 15FIX9V2JP)  
xanthan gum (UNII: TTV12P4NEE)  
dimethicone (UNII: 92RU3N3Y1O)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorGREEN (opaque, viscous) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-029-623 in 1 CASE05/18/2020
110 in 1 TRAY
1NDC:68094-029-597.5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09129205/18/2020
Labeler - Precision Dose, Inc. (035886746)

Revised: 3/2023
Document Id: 0b0a9a19-aeb8-43ba-9f3c-382dbff82479
Set id: ae8237f0-95a6-4163-b476-25c0509ef151
Version: 3
Effective Time: 20230323
 
Precision Dose, Inc.