FDA.reportPublic FDA data

Childrens Cough

Manufacturer
Wal-Mart Stores, Inc. | Guardian Drug Company
Effective date
2024-12-20
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:27

Label at a glance#

ProductChildrens Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections

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 : potassium 5 mg, sodium 5 mg store between 20 to 25°C (68 to 77°F) do not refrigerate dosing cup provided

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

PURPOSE

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

USE(S)

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • the impulse to cough to help your child get to sleep 
  • the intensity of coughing

WARNING

WARNINGS SECTION

.

DO NOT USE

OTC - DO NOT USE SECTION

in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.


ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

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

STOP USE AND A ASK DOCTOR IF

OTC - STOP USE SECTION

  •  cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness. 

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


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




OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not refrigerate
  • dosing cup provided

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

QUESTIONS?

SPL UNCLASSIFIED SECTION

1-888-287-1915

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-773-03

equate
Compare to Children's Mucinex® Cough active ingredients*
children's 
COUGH LIQUID
Dextromethorphan HBr 5mg
Cough Suppressant

Guaifenesin 100 mg

Expectorant

AGES 4 TO 12 YEARS


  • Controls cough
  • Thins and Loosens Mucus
  • Relieves chest congestion
  • Non-Drowsy
  • Alcohol Free

Cherry Flavored

4 FL OZ (118 mL)





552-Equate-4
552-Equate-4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-773-03Childrens Cough118 mL in 1 BOTTLELIQUID1184
49035-773-03Childrens Cough1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-773CHILDRENS COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WAL-MART STORES, INC.]4Current NDC, Legacy NDC, 2 package rows20241222_50a0eaa5-fa73-4d84-86fc-3546c85cf353.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-77349035-773-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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 CoughDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores, Inc.50a0eaa5-fa73-4d84-86fc-3546c85cf3532024-12-20WarningsExact identifier
ndc (package): 49035-773-03
ndc (product): 49035-773
ndc11 (package): 49035077303
spl id: 9cbd6363-5acb-4d86-ad1f-d99dca1655d2
spl set id: 50a0eaa5-fa73-4d84-86fc-3546c85cf353

Reported adverse events (FAERS/openFDA)#

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