Label: LOPERAMIDE HYDROCHLORIDE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 21, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Mint Flavor

    1 mg/7.5 mL 2 mg/15 mL

    For Hospital Use Only

  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    Distributed By
    Perrigo Company
    Allegan, MI 49010

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

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    LI1251 Rev. 04/22

  • PRINCIPAL DISPLAY PANEL - 2 mg/15 mL Cup Lid Label

    NDC 68094-129-59

    PrecisionDose™

    LOPERAMIDE Hydrochloride
    Oral SOLUTION
    2 mg/15 mL

    Shake Well Delivers 15 mL Gluten Free
    Contains 7.5 mg Sodium Hospital Use Only

    Store at 20°-25°C (68°-77°F)
    Pkg. By: Precision Dose, Inc.
    S. Beloit, IL 61080
    1253 R1

    PRINCIPAL DISPLAY PANEL - 2 mg/15 mL Cup Lid Label
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-129(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:68094-129-623 in 1 CASE05/18/2020
    110 in 1 TRAY
    1NDC:68094-129-5915 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!