Chest Congestion
FDA Label NDC 45014-150

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Accudial Pharmaceutical, Inc. for the product Chest Congestion (NDC 45014-150). 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 (in each 5 ml tsp), purpose, uses, ask a doctor before use if the child has, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml Tsp)

Guaifenesin 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

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

Directions

  • do not take more than 6 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart at right to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product.
    Do not use any other device
    • AgeDose
    children 6 years to under 12 years5 mL to 10 mL or 1-2 teaspoonfuls every 4 hours
    childen 4 years to under 6 years2.5 mL to 5 mL or 1/2-1 teaspoonful every 4 hours
    children under 4 yearsdo not use

Other Information

  • tamper evident: do not use if foil seal under bottle cap is broken or missing.
  • store between 20°-25°C (68°-77°F)

Inactive Ingredients

caramel powder, citric acid, corn syrup, FD&C red no. 40, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium saccharin.

Questions?

877-434-2036

Principal Display Panel - 118 Ml Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING
BY WEIGHT

Guaifenesin
Oral Solution

Expectorant

RELIEVES
Chest Congestion
Thins & Loosens
Mucus

For Ages 4 to under 12

Alcohol Free

Compares to
Mucinex® For Kids!

MENTHOL
FLAVOR

4 FL. OZ.
(118 mL)

NDC 45014-150-04

Chest Congestion

Principal Display Panel (118 mL Carton)

Principal Display Panel (118 mL Carton)

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