FDA.reportPublic FDA data

Vicks

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-07 01:02:38

Label at a glance#

ProductVicks DayQuil Kids and Vicks NyQuil Kids FREE OF ARTIFICIAL DYES and SUGAR COLD and COUGH plus
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure33 sections

Indications and uses

temporarily relieves common cold symptoms: cough due to minor throat & bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage and administration

take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs  adults & children 12 yrs & over  30 mL every 4 hrs  children 6 to under 12 yrs  15 mL every 4 hrs  children 4 to under 6 yrs  do not use unless directed by a doctor  children under 4 yrs  do not use

Storage and handling

each 15 mL contains: sodium 44 mg store at no greater than 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Vicks® DayQuil™ Kids FREE OF ARTIFICIAL DYES & SUGAR COLD & COUGH + MUCUS, Liquid

Drug Facts

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold symptoms:
  • cough due to minor throat & bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Do not use

OTC - DO NOT USE SECTION

  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
 adults & children 12 yrs & over 30 mL every 4 hrs
 children 6 to under 12 yrs 15 mL every 4 hrs
 children 4 to under 6 yrs do not use unless directed by a doctor
 children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains:sodium 44 mg
  • store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND SEAL AROUND THE NECK IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

MADE IN CANADA

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

SPL UNCLASSIFIED SECTION

Vicks ®NyQuil™ Kids FREE OF ARTIFICIAL DYES & SUGAR COLD & COUGH + RUNNY NOSE, Liquid

Drug Facts

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine/Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold symptoms:
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • runny nose & sneezing

Do not use

OTC - DO NOT USE SECTION

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
 adults & children 12 yrs & over 30 mL every 4 hrs
 children 6 to under 12 yrs 15 mL every 4 hrs
 children 4 to under 6 yrs do not use unless directed by a doctor
 children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains:sodium 44 mg
  • store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND SEAL AROUND THE NECK IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

MADE IN CANADA

DIST. BY: PROCTER & GAMBLE

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Convenience Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vicks® DayQuil™ Kids FREE OF ARTIFICIAL DYES & SUGAR / Vicks® NyQuil™ Kids FREE OF ARTIFICIAL DYES & SUGAR
COLD & COUGH + Convenience Pack

TRUSTEDRELIEF

VICKS ®

VALUEPACK

Vicks ® DayQuil™ Kids FREE OF ARTIFICIAL DYES & SUGAR

COLD & COUGH + MUCUS

Guaifenesin, Dextromethorphan HBr

Chest Congestion,

Thins & Loosens Mucus

Cough

Non-Drowsy

Ages 6+

FREE OF ALCOHOL & ACETAMINOPHEN

Vicks ®NyQuil™ Kids FREE OF ARTIFICIAL DYES & SUGAR

COLD & COUGH + RUNNY NOSE

Diphenhydramine HCl

Sneezing,

Runny Nose,

Cough Nighttime Relief

Ages 6+

FREE OF ALCOHOL & ACETAMINOPHEN

2 BOTTLES - 1 DAYQUIL/1NYQUIL 6 FL OZ (177 mL) EACH; TOTAL 12 FL OZ (354 mL)

312312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-31284126-312-12
84126-31084126-310-06
84126-31184126-311-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE1Q73Q2JULRIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-01full-release2026-06-01 01:18:41

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
44e9824d-1cb4-c6e9-e063-6394a90a78de1a143600-24b0-75dc-e063-6394a90afb532025-12-01WarningsExact identifier
spl set id: 1a143600-24b0-75dc-e063-6394a90afb53

Reported adverse events (FAERS/openFDA)#

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