The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories Inc. for the product Giltuss Childrens Cough And Cold (NDC 65852-011). 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 drug facts, use section, warnings, ask a doctor, otc - pregnancy or breast feeding, directions and other information, questions section, active ingredients section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients ( in each 2.5 ml) Purposes
Dextrometorphan HBr, 7.5 mg ----------------------Cough suppresant
Guafenesin, 150 mg -----------------------------------Expectorant
Phenylepryne HCL, 5 mg -----------------------------Nasal Decongestant
Uses * temporary relieves* cough due to minor throat and bronchial irritation as may occur 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 and drain bronchial tubes*temporary relieves nasal congestion due to a cold*stuffy nose
Donot use if your child is now taking a prescription monoamine oxidase inhibitor (MAOI) ( certain drugs for deppresion, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your's child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this oroduct.
Ask a doctor before use if your child has *heart desease, high blood pressure, thryroid desease, diabetes* a cough with too much phlegm ( mucus)* a persistent or chronic cough as occurs with asthma or chronic bronchitis
Ask a doctor or pharmacist before use if your child is taking any other nasal descongestant or stimulant, sedatives, tranquilizer, andndrugs used for depression, especially monoamine oxidase inhibitors (MAOIs)* When using this product do not use more than directed
Stop use and ask a Doctor if * nervousness,dizziness or sleeplesness occur* sympton do not get better within 7 days or are accompanied by fever* cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent haedache . These could be signs of serious conditions.
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 inmediatly
Directions* no take more than 6 doses in any 24 hours period * use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter
Children under 4 years ----Consult a doctor
children 4 to under 6 years------1.25 ml every 4 hours
children 6 to under 12 years-----2.5 ml every 4 hours
children 12 yeras and over -------5 ml every 4 hours
Other information
store at room temperature 15 - 30 0c* close cap tightly* save carton for complete drug facts
Call 1-787-848-9114, Monday-Friday 9AM-5PM EST
Call your doctor for medical advice in the event of side efects
Active ingredients ( in each 2.5 ml)
Dextrometorphan HBr, 7.5 mg
Guaifenesin,150 mg
Phenylephryne, 5 mg
Inactive Ingredients
Citric Acid, Flavor, Glycerin, Hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose
Keep out of reach of children.
In case of accidental overdose , get medical or professional help or contact a Poison Control Center inmediatly
Indication and Usage section
no take more than 6 doses in any 24 hours period
use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter
Children under 4 years ----Consult a doctor
children 4 to under 6 years------1.25 ml every 4 hours
children 6 to under 12 years-----2.5 ml every 4 hours
children 12 yeras and over -------5 ml every 4 hours
Purpose sectiion
Cough Suppressant
Expectorant
Nasal descongestant
Childrens 4-12
Cough & Cold
Alcohol free
Sugar free
Dye free
Non -Drowsy
Cherry Flavor
* Please review the disclaimer below.
