Label: LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride suspension

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 2, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    1 mg/7.5 mL
    2 mg/15 mL

    Mint Flavor

    For Hospital Use Only

    Drug Facts

    Close
  • Active Ingredient (in each 7.5 mL)

    Loperamide HCl 1 mg

    Close
  • Purpose

    Anti-diarrheal

    Close
  • Use

    controls symptoms of diarrhea, including Travelers' Diarrhea

    Close
  • 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 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)

    Close
  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • shake well before using
    • use as directed per healthcare professional
    Close
  • Other Information

    • each 30 mL (6 tsp) contains: sodium 13 mg
    • store between 20-25°C (68-77°F)
    • See individual label or shipper label for lot number and expiration date.
    Close
  • 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

    Close
  • How Supplied

    NDC 68094-107-62
    7.5 mL per unit dose cup
    Thirty (30) cups per shipper

    NDC 68094-108-62
    15 mL per unit dose cup
    Thirty (30) cups per shipper

    Close
  • SPL UNCLASSIFIED SECTION

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

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

    LI911
    Rev. 04/13

    Close
  • PRINCIPAL DISPLAY PANEL - 7.5 mL Cup Label

    NDC 68094-107-59

    PrecisionDose

    LOPERAMIDE Hydrochloride
    Oral Suspension
    1 mg/7.5 mL

    Delivers 7.5 mL Shake Well
    Gluten free Contains 3 mg Sodium

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

    PRINCIPAL DISPLAY PANEL - 7.5 mL Cup Label
    Close
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-107(NDC:0113-0645)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II) Loperamide Hydrochloride 1 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68094-107-62 3 in 1 CASE
    1 10 in 1 TRAY
    1 NDC:68094-107-59 7.5 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091292 02/26/2014
    Labeler - Precision Dose Inc. (035886746)
    Close