Congestion and Cough

Manufacturer
CVS PHARMACY | LNK International, Inc.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:31:53

Label at a glance#

ProductCongestion and Cough Childrens
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
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 temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants stuffy nose nasal congestion due to a cold the intensity of coughing the impulse to cough to help the child get to sleep

Dosage and administration

do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor Age Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years 5 mL every 4 hours children under 4 years do not use

Storage and handling

each 5 mL contains: sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant
Nasal decongestant

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
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • stuffy nose
    • nasal congestion due to a cold
    • the intensity of coughing
    • the impulse to cough to help the child get to sleep

Warnings

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 the child has

OTC - ASK DOCTOR SECTION

  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

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 directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • dose as follows or as directed by a doctor
AgeDose
children 6 to under 12 years10 mL every 4 hours
children 4 to under 6 years5 mL every 4 hours
children under 4 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVS™

NDC 69842-756-88

Berry Flavor

Children's
Cough &
Congestion 

DEXTROMETHORPHAN HBr,
Cough suppressant
GUAIFENESIN,
Expectorant
PHENYLEPHRINE HCl,
Nasal decongestant
Oral Solution

Compare to Mucinex®
Children's Cough & Congestion active ingredients*

Relieves: Chest congestion,
Stuffy nose, Cough

Breaks Up Mucus | No Added Alcohol
Free of: High fructose corn syrup,
Sugar, Aspirin & Ibuprofen

Ages 4-11 Years

Berry Flavor
Dosage cup included
Actual Bottle Size on Side Panel

6.8 FL OZ (201 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

*This product is not manufactured or distributed by RB Health (US) LLC,
owner of the registered trademark Mucinex® Children’s Cough &
Congestion. 50844 ORG082405688

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
V-39965

100% money back
guaranteed.
CVS.com/returnpolicy

CVS 44-056
CVS 44-056

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN12
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD12
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY12
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY12

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-756-88Congestion and CoughChildrens201 mL in 1 BOTTLE, PLASTICSOLUTION20112
69842-756-88Congestion and CoughChildrens1 in 1 CARTONSOLUTION112

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-75669842-756-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
ndc (package): 69842-756-88
ndc (product): 69842-756
ndc11 (package): 69842075688
spl id: 7cee72ed-8a47-49a4-a241-4155c233c976
spl set id: f43d97b1-aeb9-4ca5-8909-b28e7bf764f5

Reported adverse events (FAERS/openFDA)#

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