FDA.reportPublic FDA data

VICKS® NyQuil™

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-10-09 01:01:07

Label at a glance#

ProductVicks NyQuil Cough DM plus Congestion
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure11 sections

Indications and uses

temporarily relieves cold symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage

Dosage and administration

take only as directed only use 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 not use unless directed by a doctor children under 4 yrs do not use

Storage and handling

each 15 mL dose cup contains:  sodium 44 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

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cold symptoms:

• nasal congestion
• sinus congestion & pressure
• cough due to minor throat & bronchial irritation
• cough to help you sleep
• runny nose & sneezing
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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
• a sodium-restricted diet

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

  • do not use more than directed
  • 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, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or occur with a fever
  • 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.

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
  • only use dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsnot use unless directed by a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, 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™

COUGH DM + CONGESTION

Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate

  • Cough
  • Nasal Congestion
  • Sneezing, Runny Nose

Nighttime Relief

8 FL OZ (236 ml)

999999

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900041202GTIN-13: 0323900041202
EAN-13: 0323900041202
GTIN-12: 323900041202
UPC-A: 323900041202
GTIN storage (14 digits): 00323900041202		999.jpg
Data codeData Matrix21507110999.jpg
Data codeData Matrix91048397999.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-999-082024-01-30C16284748780-11030e365-5663-111a-e063-dadaa90a10e2VICKS® NyQuil™ COUGH DM + CONGESTION
69423-999-082024-01-30C16284748780-11030e365-5663-111a-e063-dadaa90a10e2VICKS® NyQuil™ COUGH DM + CONGESTION
69423-999-082024-01-30C16284748780-11030e365-5663-111a-e063-dadaa90a10e2VICKS® NyQuil™ COUGH DM + CONGESTION
69423-999-122024-01-30C16284748780-11030e365-5663-111a-e063-dadaa90a10e2VICKS® NyQuil™ COUGH DM + CONGESTION
69423-999-122024-01-30C16284748780-11030e365-5663-111a-e063-dadaa90a10e2VICKS® NyQuil™ COUGH DM + CONGESTION
69423-999-122024-01-30C16284748780-11030e365-5663-111a-e063-dadaa90a10e2VICKS® NyQuil™ COUGH DM + CONGESTION

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
69423-99969423-999-08, 69423-999-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102026-09-10daily-update2026-09-15 03:01:32
92025-10-02full-release2026-06-01 01:15:38

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
402e1fdb-a20d-33cb-e063-6294a90aebf8c4d38921-ec90-0658-e053-2a95a90a848a2025-10-02WarningsExact identifier
spl set id: c4d38921-ec90-0658-e053-2a95a90a848a

Reported adverse events (FAERS/openFDA)#

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