Childrens Chest Congestion Relief Solution
FDA Label NDC 0363-7504

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Company for the product Childrens Chest Congestion Relief (NDC 0363-7504). 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 other, active ingredient (in each 5 ml), purpose, uses, otc - ask doctor, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each 5 Ml)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Uses

  • ▪helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Otc - Ask Doctor

Ask a doctor before use if the child has

  • ▪cough that occurs with too much phlegm (mucus)
  • ▪persistent or chronic cough such as occurs with asthma

Otc - Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Otc - 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.

Directions

  • ▪do not take more than 6 doses in any 24-hour period
  • ▪measure only with dosing cup provided
  • ▪do not use dosing cup with other products
  • ▪mL = milliliter
    • AgeDose

    children 6 years to under 12 years

    5 mL – 10 mL every 4 hours

    children 4 years to under 6 years

    2.5 mL – 5 mL every 4 hours

    children under 4 years

    do not use

Other Information

  • ▪each 5 mL contains: sodium 3 mg
  • ▪store at room temperature
  • ▪do not refrigerate
  • ▪dosing cup provided

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, natural and artificial flavors, potassium citrate propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel - 120 Ml

NDC 0363-7504-04

Children's
Chest Congestion Relief

Guaifenesin

Oral Solution, USP

Expectorant

  • Relieves Chest Congestion
  • Breaks up Mucus
  • Alcohol Free

    • GrapeFlavor

    Naturally and Artificially Flavored

    4 FL OZ(120 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.® Chest Congestion

    Distributed by:

    WALGREEN CO.

    200 WILTMOT RD. DEERFIELD, IL 60015

    Children's Chest Congestion Relief Grape Flavor (Mucinex 01)

    Children's Chest Congestion Relief Grape Flavor (Mucinex 01)

* Please review the disclaimer below.