FDA.reportPublic FDA data

CVS Children's Stuffy Nose and Cold

Manufacturer
CVS PHARMACY, INC
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-21 02:02:20

Label at a glance#

ProductCVS
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 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: ▪ nasal congestion due to a cold ▪ stuffy nose

Dosage and administration

▪ do not give 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 10 mL every 4 hours Children 4 years 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 ▪ very low sodium  ▪ store at room temperature ▪ do not refrigerate ▪ dosing cup provided

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL)

Guaifenesin, USP 100 mg

Phenylephrine HCl, 2.5 mg

Purposes

OTC - PURPOSE SECTION

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:
    • nasal congestion due to a cold
    • stuffy nose

Warnings

WARNINGS SECTION

Do not use 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

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

When using this product

OTC - WHEN USING SECTION

  • Do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not give 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

10 mL every 4 hours

Children 4 years to under 6 years

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
  • very low sodium 
  • store at room temperature
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Package Label-Principal Display Panel 4 FL OZ (118 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Children’s Mucinex® Stuffy Nose & Cold

NDC 69842-487-04

Children's Stuffy Nose & Cold Relief

Guaifenesin

Expectorant

Phenylephrine Hcl

Nasal Decongestant

  • Stuffy Nose
  • Chest Congestion
  • Breaks Up Mucus

Dosage Cup Included

For Ages 4 & Over

Dye Free
Mixed Berry Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

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

Distributed by:


CVS Children's Stuffy Nose and Cold Relief Syrup
CVS Children's Stuffy Nose and Cold Relief Syrup

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-48769842-487-04

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
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-10full-release2026-06-01 01:21:40

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
CVSCHILDRENS STUFFY NOSE AND COLDCVS PHARMACY, INC6cff265d-94a3-4617-a366-fe970d97f05a2026-08-19WarningsExact identifier
ndc (package): 69842-487-04
ndc (product): 69842-487
ndc11 (package): 69842048704
spl id: e5050d2d-a616-477d-83ac-c628b888a275
spl set id: 6cff265d-94a3-4617-a366-fe970d97f05a

Reported adverse events (FAERS/openFDA)#

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