Childrens Multi-symptom Cold
FDA Label NDC 68016-134

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

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.

Active Ingredients

Drug Facts

Active ingredients

(in each 5 mL teaspoon)

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg

Purpose

Purpose

 Cough suppressant
 Expectorant
 Nasal decongestant

Keep Out Of Reach Of Children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control center right away.

Uses

Uses

  • helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive
    • temporarily relieves these symptoms occurring with a cold:
      • cough due to minor throat and bronchial irritation
        • nasal congestion
          • stuffy nose

Warnings

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

Ask a doctor before use if the child has

  • heart disease
    • high blood pressure
      • thyroid disease
        • diabetes
          • cough that occurs with too much phlegm (mucus)
            • persistent or chronic cough such as occurs with asthma

When Using This Product


When using this product

  • do not use more than directed

Stop Use And Ask A Doctor

Stop use and ask a doctor if

  • your child gets nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or occur with fever
      • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
      • These could be signs of a serious condition.

Directions

Directions

  • do not take more than 6 doses in any 24-hour period
  • 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

Other information

  • each 5 mL teaspoon contains: sodium 3 mg
    • store between 15-30 ° C (59-86° F)
      • do not refrigerate
        • dosing cup provided

Inactive Ingredients

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?

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

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

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