Active Ingredients
Active Ingredients
Guafenesin, 400 mg
Giltuss Ex Expectorant Solution
FDA Label NDC 65852-008
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 Giltuss Ex Expectorant (NDC 65852-008). 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, if pregnant or breast -feeding, 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
Uses
Purpose
Expectorant
Uses
- helps loosen phlegm ( mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
Warnings
Warnings
- Ask a doctor before use if you have , cough that occurs with too much phlegm ( mucus) , persistent or chronic cough such occurs with smoking, asthma, or chronic bronchitis or emphysema
Stop Use
Stop use and ask a doctor if cough lasts for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. A persistant cough may be a sign of a serious condition
If Pregnant Or Breast -Feeding
If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately
Directions
Directions
Do not take more than 6 doses in any 24 hours period
Use enclosed dosing cup
Directions (Directions)
Keep dosing cup for use this product
ml= mililiters
Adults and children 12 years & over 10 ml every 4 hours
children 6 to under 12 years of age 5 ml every 4 hours
children 4 to under 6 years of age 2.5 ml every 4 hours
children under 4 years of age Consult a doctor
Other Information
Other information
Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS
Directions (Directions)
Inactive Ingredients
Inactive Ingredients
Citric acid, glycerin, methylparaben,natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate,
Directions (Directions)
Questions And Comments
Questions and comments?
Call 1-787-848-9114, Monday-Friday 9AM-5PM EST
call your doctor for medical advice in the event of side effects
Directions (Directions)
Indication And User Section
Indication and usage
Do not take more than 6 doses in any 24- hours period.
Keep sosage cup for use with this product
Adults and children 12 years and over 10 ml every 4 hours
Children 6 to under 12 years of age 5ml every 4 hours
Children 4 to under 6 years of age 2.5ml ever 4 hours
Children under 4 years of age Consult a doctor
Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental overdose, get medical or professional help or contact a Poison Control center immediately
Package Label.Principal Display Panel
Maximun strength Giltuss EX Expectorant
Guafenesin 400 mg
Alcohol free, sugar free, Dye free, Non-Drowsy
Chest congestion, Phlegm & Mucus
Tutti Frutti Flavor
4 floz 118 ml
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