Active Ingredients
Active ingredients ( in each 5 ml) Purpose
Guaifenesin, 200 mg ----------------------------------------Expectorant
Childrens Giltuss Ex Expectorant Solution
FDA Label NDC 65852-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories Inc. for the product Childrens Giltuss Ex Expectorant (NDC 65852-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, warnings, stop use section, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Directions
Directions
Do not take more than 6 doses in any 24 hours period
use enclosed dosing cup
Keep dosage cup for use with this product
ml= mililiters
children under 4 years of age Consult a doctor
children 4 to under 6 years of age 2.5 ml every 4 hours
children 6 to under 12 years of age 5 ml every 4 hours
Adults and children 12 years & over 10 ml every 4 hours
Other Information
Other information
Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredients
Inactive Ingredients
Citric Acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose
Questions Or Comments
Questions or comments?
Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST
Call your doctor for medical advice in the event of side effects.
Indication For Use Section
indication an user section
Do not take more than 6 doses in any 24 hours period
use enclosed dosing cup
Keep dosage cup for use with this product
ml= mililiters
children under 4 years of age Consult a doctor
children 4 to under 6 years of age 2.5 ml every 4 hours
children 6 to under 12 years of age 5 ml every 4 hours
Adults and children 12 years & over 10 ml every 4 hours
Package Label.Principal Display Panel
Children 4 -12
Children's Giltuss EX
Expectorant
Guaifenesin, 200 mg
Alcohol free, Sugar free, Dye free, Non-Drowsy
Chest congestion liquifies and loosen phlegm and mucus
Tutti Frutti flavor
4 floz 118 ml
* Please review the disclaimer below.
