FDA.reportPublic FDA data

Childrens Chest Congestion Relief

Manufacturer
WALGREENS COMPANY
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:18:18

Label at a glance#

ProductChildrens Chest Congestion Relief
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

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

Dosage and administration

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 Age Dose 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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

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 SECTION

Stop use and ask a doctor ifcough 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 SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-7504-04

Compare to Children’s Mucinex ®Chest Congestion active ingredient ††

children's

Chest Congestion Relief

GUAIFENESIN 100 mg

ORAL SOLUTION, USP/

EXPECTORANT

ALCIHOL FREE

  • Breaks up the mucus that causes congstion

AGES 4 YEARS & OLDERS

GRAPE FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

4 FL OZ (120 mL)

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

†Walgreens Pharmacist Survey

††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

Walgreens

100% SATISFACTION GUARANTEED

walgreen.com ©2020 Walgreens Co.

Walgreens Childrens Chest Congestion Relief Grape Flavor
Walgreens Childrens Chest Congestion Relief Grape Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN8
310604guaifenesin 20 MG/ML Oral SolutionSCD8
310604guaifenesin 100 MG per 5 ML Oral SolutionSY8
310604guaifenesin 100 MG per 5 ML Oral SyrupSY8
310604guaifenesin 200 MG per 10 ML Oral SolutionSY8
310604guaifenesin 300 MG per 15 ML Oral SolutionSY8
310604guaifenesin 400 MG per 20 ML Oral SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7504-04Childrens Chest Congestion Relief120 mL in 1 BOTTLESOLUTION1208
0363-7504-04Childrens Chest Congestion Relief1 in 1 CARTONSOLUTION18

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-75040363-7504-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Chest Congestion ReliefGUAIFENESINWALGREENS COMPANYc1382512-e6f3-4bdf-a9e6-4f68dd5ea5532025-11-26WarningsExact identifier
ndc (package): 0363-7504-04
ndc (product): 0363-7504
ndc11 (package): 00363750404
spl id: 447cb147-2a48-0f5c-e063-6294a90a196b
spl set id: c1382512-e6f3-4bdf-a9e6-4f68dd5ea553

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.