The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories Inc. for the product Giltuss Childrens Allergy Plus (NDC 65852-018). 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, indication and usage section, keep out of reach of children section, inactive ingredient section, purpose section, question section, warnings section, dosage and administration section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients ( in each 5 mL) Purpose
Chlorpheniramine maleate, USP 2 mg ------------------Antihistamine
Dextromethorphan HBr, USP 10 mg -----------------------Cough supressant
Phenylephrine HCl, USP 5 mg -------------------------------Nasal decongestant
indication and usage section
Not take more than 6 doses in any 24-hour period
Use enclosed dosing cup
Keep dosage cup for use this product
ML=Milliliter
Children undre 6 years, consult the doctor
Children 6 to under 12 years, 5 ml every 4 to 6 hours
Adults and children 12 years and over, 10 ml every 4 to 6 hours
Keep out of reach of children section
In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive ingredient section
Citric acid, flavor, glycerin, metylparaben, propylparaben, purified water, and sucralose.
Purpose section
Antihistamine
Cough Suppressant
Nasal Descongestant
Question section
Call 1-787-848-9114, Monday-Friday 9AM-5PM EST.
Call your doctor for medical advice in the event of side effects
Warnings Section
Do not use to sedate a child or to makea child sleepy
in a child who is taking a prescription monoamine oxidase inhibitor(MAOI)(certain drugs for depression, psychiatric, or emotional condition, or Parkingson's disease), or for 2 weeks after stopping the MAOI drug.
If you do not know if your child's prescription drug contains a MAOI, ask a doctor or pharmacistbefore taking this products.
Dosage and administration section
Not take more than 6 doses in any 24-hour period
Use enclosed dosing cup
Keep dosage cup for use this product
ML=Milliliter
Children undre 6 years, consult the doctor
Children 6 to under 12 years, 5 ml every 4 to 6 hours
Adults and children 12 years and over, 10 ml every 4 to 6 hours
Principal panel
Children 6-12
Children's Giltuss Allergy Plus
Cough & Congestion
Alcohol free, Sodium free, Sugar free,Dye free
Sneezing, runny nose, cough, itchy & watery eyes, sinus pressure, stuffy nose
Tutti Frutti flavor
4 floz ( 118 mL)
* Please review the disclaimer below.
