Active Ingredients
Active Ingredients ( in Each 5 ml) Purposes
Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant
Guaifenesin, 100 mg --------------------------------------Expectorant
Childrens Giltuss Honey Cough And Chest Congestion Solution
FDA Label NDC 65852-003
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 Honey Cough And Chest Congestion (NDC 65852-003). 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, ask a doctor before use if the child has, stop use, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Uses
Uses
Temporary relieves:
Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing , the impulse to cough to help your child get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive
Warnings
Warnings
Do not use
If your child is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If The Child Has
Warnings
Ask a doctor before use if your child has, cough that occurs with too much phlegm (mucus) , a persistent or chronic cough as occurs with asthma.
Stop Use
Stop use and ask a doctor if
cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.
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 Poisson Control center immediately
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= milliliters
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
Carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water,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 And Usage Section
Indication and usage 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= milliliters
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
Alcohol free, Dye free, Non-drowsy
True source certified honey
Children's Giltuss Honey
Cough & Chest Congestion
Cough & cold, chest congestion, liquifies and loosen phlegm and mucus
Honey lemon flavor
4 floz 118 ml
* Please review the disclaimer below.
