GADAVYT LOPERAMIDE HCL - loperamide hydrochloride liquid 
Gadal Laboratories Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active Ingredient (in each 5mL teaspoonful)            Purpose

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

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 stool

Ask a Doctor before use if you have

Stop use and ask a doctor if diarrhea lasts for more than 2 days

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

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

Directions

Use enclosed dosage cup to accurately measure dosage as noted below


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 ingredients

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

Questions or comments?

Call 305-382-3288

www.gadallaboratories.com

loperamide
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)

Revised: 5/2013
Document Id: 7aa6375e-6789-4465-967b-9d3ddeac3635
Set id: fa02a809-167c-4978-8226-6b42479b91e0
Version: 1
Effective Time: 20130522
 
Gadal Laboratories Inc