The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories, Inc for the product Giltuss Childrens Cough And Chest Congestion (NDC 65852-019). 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 indication and usage section, active ingredient section, purpose section, warnings, keep out of reach of childrens section, question section, ask a doctor section, stop use section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Indication and usage section
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, consult a doctor
Children 4 to under 6 years, 2.5 ml every 4 hours
Children 6 to under 12 years, 5 ml every 4 hours
Children 12 years and over, 10 ml every 4 hours
Active ingredient section
(in each 5 ml)
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Inactive ingredient
Citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water and sucralose.
Purpose section
Cough suppressant
Expectorant
Warnings
Do not use if you child is now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional condition, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.
Keep out of reach of childrens section
In case of a overdose, get medical help or contacta Poison Control Center right away
Question section
Call 1-787-848-9114 Monday-Friday 9AM-5PM EST.
Call your doctor for medical advice in the event of side effects.
Ask a doctor section
Ask a doctor before use if the child has
cough that occurs with much phlegm(mucus)
a breathing problem or persistent or chronic cough that lasts such as occurs with asthma.
stop use section
Stop use ans ask doctor of pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever, cough comes back or is accompanied by fever rash or persistent headache.
Dosage and Administratiion section
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, consult a doctor
Children 4 to under 6 years, 2.5 ml every 4 hours
Children 6 to under 12 years, 5 ml every 4 hours
Children 12 years and over, 10 ml every 4 hours
Package Label. Principal Display Panel
G Children, ninos 4-12
Children's
Giltuss
Cough & Chest Congestion
Tos y Congestion de Pecho
Alcohol Free. Sugar Free. Dye Free. Non-Drowsy
Sin Alcohol. Sin Azucar. Sin Colorantes. No causa sueno.
COUGH & COLD, CHEST CONGESTION, LIQUIFIES
AND LOOSSEN PHLEGM AND MUCUS
TOS Y CATARRO, CONGESTION DE PECHO,
LIQUA Y SUELTA LA FLEMA Y EL MOCO
RASBERRY FLAVOIR.
SABOR A FRAMBUESA. 4 FL OZ (118 ml)
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