Active Ingredients
Drug Facts
Active ingredients
(in each 5 mL teaspoon)
Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Childrens Multi-symptom Cold (NDC 68016-134). 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, purpose, keep out of reach of children, uses, warnings, ask a doctor before use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredients
(in each 5 mL teaspoon)
Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control center right away.
Uses
Warnings
Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.
Ask a doctor before use if the child has
When using this product
Stop use and ask a doctor if
These could be signs of a serious condition.
Directions
Age Dose
Children 6 years to under 12 years 2 teaspoons every 4 hours
Children 4 years to under 6 years 1 teaspoon every 4 hours
Children under 4 years Do not use
Other information
Inactive ingredients
citric acid anhydrous, D and C red #33,dextrose, FD and C blue #1, FD and C red # 40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944
NDC 68016-134-00
*COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX®Multisymptom Cold
Premier Value®
CHILDREN’S MULTI- SYMPTOM COLD
EXPECTORANT
COUGH SUPPRESSANT
NASAL DECONGESTANT
Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg
* Stuffy Nose
* Cough
* Chest Congestion
* Breaks up Mucus
Alcohol free
For ages 4 to 12
Very Berry Flavor
4 FL OZ (118mL)
INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Children’s Mucinex® Multisymptom Cold
If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
BX-010
* Please review the disclaimer below.