NyQuil

Manufacturer
Select Consumer Group | Selecet Consumer Group
Effective date
2026-10-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-20 03:03:41

Label at a glance#

ProductNyQuil Cold and Flu w/VapoCOOL, 4ct
Active ingredientDOXYLAMINE SUCCINATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Indications and uses

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation cough to help you sleep sore throat headache minor aches & pains fever runny nose & sneezing

Dosage and administration

Directions take only as directed do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Label contents#

Full prescribing information#

​Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

​Purpose

Pain reliever/fever red

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing

Warnings

WARNINGS SECTION

​Liver warning

SPL UNCLASSIFIED SECTION

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert

SPL UNCLASSIFIED SECTION

Allergy Alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning

SPL UNCLASSIFIED SECTION

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

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. 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

Directions

  • take only as directed
  • do not exceed 8 caplets per 24 hrs
adults & children 12 yrs & over2 caplets with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

SPL UNCLASSIFIED SECTION

Other information

  • store at no greater than 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
corn starch, D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Questions?1-800-362-1683

NyQuil Cold & Flu w/VapoCOOL, 4ct (PE-free), Travel BASIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS

NyQuil™

COLD & FLU

Acetaminophen, Docylamine

Succinate, Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCOOL

COATED

4 Coated Caplets

nyqnyq

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708219126GTIN-13: 0655708219126
EAN-13: 0655708219126
GTIN-12: 655708219126
UPC-A: 655708219126
GTIN storage (14 digits): 00655708219126
2621912028 - NyQuil - 1917-2.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85237-191785237-1917-0, 85237-1917-1
66715-6205

Ingredients#

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

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

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
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
ndc (product): 66715-6205

Reported adverse events (FAERS/openFDA)#

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