Label: HANDY SOLUTIONS ANTI-DIARRHEAL- loperamide hydrochloride tablet

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

Drug Label Information

Updated March 15, 2023

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  • Drug Facts

  • Active ingredient (in each caplet)

    Loperamide Hydrochloride 2 mg

    Purpose

    Antidiarrheal

  • Uses

    Controls the symptoms of diarrhea, including Traveler’s 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 stools

    Ask a doctor before use if you have

    • a fever
    • mucus in 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 more than 2 days
    • you get abdominal swelling or bulging. These may be signs of a serious condition.

    If you are pregnant or breast feeding,

    ask a health professional before use.

    Keep this and all drugs out of the reach of children.

    In case of accidental overdose, contact a physician or Poison Control Center right away.

  • Directions

    do not use more than directed
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea

     Adults and children (12 years and older): Take 2 caplets after the first
    loose bowel movement
    followed by 1 caplet after each
    subsequent loose bowel
    movement but no more than
    4 caplets in 24 hours.
     Children under 12 years: Do not give to children under
    12 years of age.

  • Other information

    • store between 68º - 77ºF (20º - 25ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packet

  • Inactive ingredients

    anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow # 10, FD&C blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

  • Questions or comments?

    1-800-525-5097

  • Package Labeling:

    HS Anti-Diarrheal

  • INGREDIENTS AND APPEARANCE
    HANDY SOLUTIONS ANTI-DIARRHEAL 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-162(NDC:47682-200)
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Product Characteristics
    Colorgreen (green) Score2 pieces
    ShapeOVAL (OVAL) Size10mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-162-011 in 1 CARTON09/21/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409109/21/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-162) , repack(67751-162)
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