FDA.reportPublic FDA data

Vicks Childrens NyQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2021-02-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:53:27

Label at a glance#

ProductVicks Childrens NyQuil Cold and Cough Multi-Symptom Relief
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 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 do not exceed 4 doses per 24 hrs only use the dose cup provided 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 23 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 sleep

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • do not exceed 4 doses per 24 hrs
  • only use the dose cup provided

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

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 23 mg
  • Store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, FD&C Red No. 40, flavor, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

Children's
NyQuil ™

COLD & COUGH
Multi-Symptom Relief

Chlorpheniramine maleate, Dextromethorphan HBr

  • Sneezing
  • Runny Nose
  • Cough

Free of Alcohol & Acetaminophen

Berry Flavor
8 FL OZ (236 ml)

556556

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-937-082021-02-11C16284748780-1ba0f9c33-324f-a910-e053-dadaa90a0b85VICKS ® Children's NyQuil ™
37000-937-082021-01-29C16284748780-1ba0f9c33-324f-a910-e053-dadaa90a0b85VICKS ® Children's NyQuil ™

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
37000-93737000-937-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
f431d7be-59b2-8ed4-e053-2995a90a8211911e2f0d-aa4a-73c0-e053-2995a90a3d362023-02-08WarningsExact identifier
spl set id: 911e2f0d-aa4a-73c0-e053-2995a90a3d36

Reported adverse events (FAERS/openFDA)#

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