FDA.reportPublic FDA data

Vicks NyQuil Childrens

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-08-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:26:40

Label at a glance#

ProductVicks NyQuil Childrens
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure18 sections

Indications and uses

temporarily relieves cold symptoms: cough due to minor throat & bronchial irritation sneezing runny nose

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 6 hrs children 6 to under 12 yrs 15 mL every 6 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 13 mg Store at no greater than 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 15 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cold symptoms:

  • cough due to minor throat & bronchial irritation
  • sneezing
  • runny nose

Warnings

WARNINGS SECTION

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.
  • to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 1 week, tends to recur, or is accompanied by 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.

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 & over30 mL every 6 hrs
children 6 to under 12 yrs15 mL every 6 hrs
children 4 to under 6 yrsdo not use unless directed by a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 13 mg
  • Store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if printed shrinkband is broken or missing.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

NyQuil ™
children's

COLD & COUGH

Chlorpheniramine maleate, Dextromethorphan HBr

Sneezing, Runny Nose
Cough

Free of Alcohol & Acetaminophen

8FL OZ (236 mL)

AGES 6+

984984

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
69423-98469423-984-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
SORBITOL506T60A25RIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
05f693ae-a0f5-17ee-e063-6394a90a3e3cecf75e75-b7d5-0135-e053-2995a90a2f412023-09-22WarningsExact identifier
spl set id: ecf75e75-b7d5-0135-e053-2995a90a2f41

Reported adverse events (FAERS/openFDA)#

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