Childrens Cold, Cough And Sore Throat
FDA Label NDC 68016-224

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 Cold, Cough And Sore Throat (NDC 68016-224). 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, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Drug Facts

Active ingredients

(in each 10 mL or 2 teaspoons)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg

Purpose

Purpose

Pain reliever/fever reducer
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

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • minor aches and pains
  • headache
  • stuffy nose
  • sore throat
  • fever
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if your child if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen


    • Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do Not Use

  • with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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 Your Child Has



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

Ask A Doctor Or Pharmacist Before Use If

  • your child is taking the blood  thinning drug warfarin

Stop Use And Ask A Doctor If

  • redness or swelling is present
  • nervousness, dizziness or sleeplessness occur
  • new symptoms occur
  • pain, nasal congestion or cough gets worse or lasts more that 5 days
  • fever gets worse or lasts more than 3 days
  • cough comes back, or occurs with rash or headache that lasts.


    • These could be signs of a serious condition.

Directions

Directions


  • do not use more than directed (see Overdose warning)
  • shake well before using
  • do not use more than 5 doses in any 24-hour period
  • if needed, repeat dose every 4 hours while symptoms last
  • do not use more than 5 days unless directed by a doctor
  • use dose cup


    • Age                                                                       Dose
    Children 6 to under 12 years of age                          2 teaspoonfuls
    Children under 6 years of age                                  do not use

Other Information

  • each 10 mL (2 tsp)  contains: sodium 5 mg
  • store between 15-30 ° C (59-86° F)
  • do not refrigerate
  • dosing cup provided

Overdose Warning

When using this product

  • do not use more than directed (see Overdose warning)
  • Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients

anhydrous citric acid,edetate disodium,  FD and C Blue #1, FD and C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water,  sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

 1-877-798-5944

Product Label

NDC 68016-224-00

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX® COLD, COUGH, and SORE THROAT LIQUID

Premier Value®
Children's Cold, Cough, and Sore Throat

Acetaminophen / Guaifenesin / Dextromethorphan HBr / Phenylephrine HCL

PAIN RELIEVER / FEVER REDUCER
EXPECTORANT
COUGH SUPPRESSANT
NASAL DECONGESTANT

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg

    * Cough
    * Sore Throat
    * Nasal Congestion
    * Chest Congestion


For ages 6 to 12

Mixed Berry Flavor
4 FL OZ (118mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

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® Cold, Cough and Sore Throat Liquid
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
BX028

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