Label: WELMATE ANTI DIARRHEAL LOPERAMIDE HCL SOFTGELS- loperamide hydrochloride capsule

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

Drug Label Information

Updated November 1, 2022

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  • Drug Facts

  • Active ingredient (in each softgel)

    Loperamide HCl 2 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.

    Heart alert: Taking more than directed can cause serious heart problems or death.

    Do not use:

    • if you have bloody or black stool
    • in children under 12 years of age

    Ask a doctor before use if you have:

    • fever
    • mucus in the stool
    • a history of liver disease
    • a history of abnormal heart rhythm
    • Ask a doctor before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

    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 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 (1-800-222-1222) right away.

  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • not for use in children under 12 years of age
    • adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours
  • Other information

    • do not use if blister unit is torn or open
    • store at 20°- 25°C (68° - 77°F)
  • Inactive ingredients

    butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.

  • Questions?

    call toll-free 1-800-935-6737

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    WELMATE ANTI DIARRHEAL LOPERAMIDE HCL SOFTGELS 
    loperamide hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code LP2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-102-242 in 1 CARTON08/22/2020
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02185508/22/2020
    Labeler - YYBA CORP (006339772)
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