GADAVYT LOPERAMIDE HCL- loperamide hydrochloride liquid

Gadavyt Loperamide HCl by

Drug Labeling and Warnings

Gadavyt Loperamide HCl by is a Otc medication manufactured, distributed, or labeled by Gadal Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)