Childrens Mucus Relief Solution
FDA Label NDC 63868-770

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 Manufacturing Assn for the product Childrens Mucus Relief (NDC 63868-770). 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
  • Tamper evident: do not use if printed inner seal under cap is torn or missing.
  • store at room temperature
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate ,sorbitol, sucralose, xanthan gum.

Principal Display Panel - 118 Ml Bottle Carton

QC QUALITY CHOICE NDC 63868-770-04

Children's
Mucus relief

Expectorant

Guaifenesin

Oral Solution, USP

Each Dose of Grape Flavored

Children’s Mucus Relief:

Relieves Chest Congestion

  •   Breaks up Mucus


    • Alcohol Free

    •  See New Dosing Information

      • Grape
      Flavor

      4 FL OZ
      (118 mL)

      IMPORTANT:

      Keep this carton for future reference on full labeling.

      DOSAGE CUP INCLUDED

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

      Distributed by C.D.M.A.,Inc©

      43157 W. Nine Mile

      Novi, MI 48376-0995

      www.qualitychoice.com

      Questions: 248-449-9300

      QC 100% Satisfaction Guaranteed.

      Quality Choice Childrens Mucus Relief Expectorant Grape Flavor 4 Fl Oz (Mucinex 01)

      Quality Choice Childrens Mucus Relief Expectorant Grape Flavor 4 Fl Oz (Mucinex 01)

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