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Gadavyt Loperamide HCl (Gadal Laboratories Inc)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE in 1 CARTON (53113-657-04) > 118 mL in 1 BOTTLE Label Information

Complete Gadavyt Loperamide HCl Information

  • 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


  • INGREDIENTS AND APPEARANCE
    GADAVYT LOPERAMIDE HCL 
    loperamide hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-657
    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 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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     
    Shape Size
    Flavor CHERRY (Cherry) , MINT (Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53113-657-04 1 in 1 CARTON
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2013
    Labeler - Gadal Laboratories Inc (841305639)