Childrens Chest Congestion Relief
FDA Label NDC 68016-157

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 Chest Congestion Relief (NDC 68016-157). 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 ingredient, purpose, keep out of reach of children, uses, warnings, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Purpose

Expectorant

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

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Warnings

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


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 condition.

Directions

  • do not take more than 6 doses in any 24-hour period
    • Aptapharmapv Childccrelief1 Label (Aptapharmapv Childccrelief1)

    Aptapharmapv Childccrelief1 Label (Aptapharmapv Childccrelief1)

Other Information

  •   each 5 mL teaspoon contains: sodium 3 mg
  • store between 20-25 ° C (68-77° F)
  • do not refrigerate
  • dosage cup provided
  • Keep carton for full directions for use

Inactive Ingredients

citric acid anhydrous, 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

1-877-798-5944

Product Label

NDC 68016-157-04
*COMPARE TO THE ACTIVE INGREDIENTS IN CHILDRENS MUCINEX® CHEST CONGESTION

Premier Value®

Childrens Chest Congestion Relief

Guaifenesin Oral Solution, USP
EXPECTORANT

Relieves Chest Congestion
Thins and Loosens Mucus

Alcohol-Free
For Ages 4 to 12

Grape 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 Childrens Mucinex®

If for Any reason you are not satisfied with this product, please 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-011

Aptapharmapv Childccrelief Label (Aptapharmapv Childccrelief)

Aptapharmapv Childccrelief Label (Aptapharmapv Childccrelief)

* Please review the disclaimer below.