GADAVYT LOPERAMIDE HCL (LOPERAMIDE HYDROCHLORIDE) LIQUID [GADAL LABORATORIES INC]

GADAVYT LOPERAMIDE HCL (LOPERAMIDE HYDROCHLORIDE) LIQUID [GADAL LABORATORIES INC]
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NDC 53113-657-04
Set ID fa02a809-167c-4978-8226-6b42479b91e0
Category HUMAN OTC DRUG LABEL
Packager Gadal Laboratories Inc
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredient (in each 5mL teaspoonful)            Purpose

    Loperamide HCl, 1mg ....................................................Antidiarrheal

  • PURPOSE

    Purpose

    Antidiarrheal

  • INDICATIONS & USAGE

    Uses

    controls the symptoms of diarrhea, including Traveler's Diarrhea.

  • WARNINGS

    Warnings

    Allergy Alert:Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

  • DO NOT USE

    Do not use if you have bloody or black stool

    Ask a Doctor before use if you have

    • high fiver (greater than 101 degrees F)
    • mucus present in your stool
    • a history of liver disease
      Ask a doctor or pharmacist before use if you are taking antibiotics
    Stop use and ask a doctor if diarrhea lasts for more than 2 days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use

  • DOSAGE & ADMINISTRATION

    Directions

    Use enclosed dosage cup to accurately measure dosage as noted below

    • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
    • find right dosage on chart
    • if possible, use weight to dose; otherwise, use age.

    Adults and children 12 years and older
    4 teaspoonfuls (1 dosage cup) after the first loose bowel movement;
    2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement;
    but no more than 8 teaspoonfuls a day
    Children 9-11 (60-95 lbs)
    2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement;
    1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement;
    but no more than 6 teaspoonfuls a day
    Children 6-8 (48-59 lbs)
    2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement;
    1 teaspoonfuls (1/4 dosage cup) after each subsequent loose bowel movement;
    but no more than 4 teaspoonfuls a day
    Children under 6 years (Up to 47 lbs)
    Ask a doctor (not intended for use in children under 6 years old
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, propylene glycol, methylparaben, propylparaben, glycerin, sucralose, cherry flavor, peppermint flavor, sorbitol, purified water

  • QUESTIONS

    Questions or comments?

    Call 305-382-3288

    www.gadallaboratories.com

  • PRINCIPAL DISPLAY PANEL

    loperamide
  • INGREDIENTS AND APPEARANCE
    GADAVYT LOPERAMIDE HCL 
    loperamide hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-657
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry) , MINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-657-041 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2013
    Labeler - Gadal Laboratories Inc (841305639)

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