Label: ANTI DIARRHEAL- loperamide hcl solution

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

Drug Label Information

Updated September 13, 2011

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  • Active ingredient (in each 5 mL)

    Loperamide HCl 1 mg

  • Purpose

    Anti-diarrheal

  • Uses

    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

    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.

  • Directions

    • 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.
    • only use attached measuring cup to dose product
    adults and children 12 years and over4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours
    children 9-11 years (60-95 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 6 teaspoonfuls in 24 hours
    children 6-8 years (48-59 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 4 teaspoonfuls in 24 hours
    children under 6 years (up to 47 lbs)ask a doctor
  • Other information

    • do not use if carton is opened or if printed plastic neckband is broken or missing
    • store between 20°-25°C (68°-77°F)
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Loperamide HCl 1mg

  • INGREDIENTS AND APPEARANCE
    ANTI DIARRHEAL 
    loperamide hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-978(NDC:0113-0377)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE1 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorORANGE (amber, clear, pale) Score    
    ShapeSize
    FlavorCHERRY (cherry mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-978-041 in 1 CARTON
    1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07324307/13/1992
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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