FDA.reportPublic FDA data

NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-10-02
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:56:23

Label at a glance#

ProductNyQuil Severe Plus VapoCOOL Cold and Flu
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat 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 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

Storage and handling

do not exceed 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

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

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

  • 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 if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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
  • pain, nasal congestion, 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.

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.

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
  • 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

STORAGE AND HANDLING SECTION

  • do not exceed 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

Product repackaged and distributed with permission of manufacturer by:
Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404

NyQuil™ Severe Plus VapoCOOL™ C & F - Lil' Drug Store PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NyQuil™

SEVERE+

VICKS ® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

4

Coated Caplets

Lil'

DrugStore ®

PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch CartonPRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton

NyQuil™ Severe + VapoCOOL™ C & F - CVP Health PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NyQuil™

SEVERE+

VICKS ® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

[caplet image]

Nighttime Relief

4

Coated Caplets

[CVP ® HEALTH logo]

PDP/PackagePDP/Package

NyQuil™ SEVERE+ VICKS® VapoCOOL™ - TRAVEL BASIX PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NyQuil™

SEVERE+

VICKS® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

[caplet image]

4

Coated Caplets

[TRAVEL BASIX logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1546881acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral TabletPSN7
1546881acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD7
1546881APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6405-2NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX2 in 1 CARTONTABLET, COATED27
66715-6405-2NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX2 in 1 POUCHTABLET, COATED27
66715-6581-2NyQuil Severe Plus VapoCOOL Cold and Flu, CVP HEALTH2 in 1 CARTONTABLET, COATED27
66715-6581-2NyQuil Severe Plus VapoCOOL Cold and Flu, CVP HEALTH2 in 1 POUCHTABLET, COATED27
66715-9905-2NyQuil Severe Plus VapoCOOL Cold and Flu2 in 1 POUCHTABLET, COATED27
66715-9905-2NyQuil Severe Plus VapoCOOL Cold and Flu2 in 1 CARTONTABLET, COATED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6405NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU, CVP HEALTH (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU, TRAVEL BASIX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, 2 package rows20231003_e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b.zip
66715-6581NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU, CVP HEALTH (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU, TRAVEL BASIX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, 2 package rows20231003_e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b.zip
66715-9905NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU, CVP HEALTH (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU, TRAVEL BASIX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, Legacy NDC, 2 package rows20231003_e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-990566715-9905-2
66715-658166715-6581-2
66715-640566715-6405-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 60 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
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
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIXACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b2023-10-02WarningsExact identifier
ndc (package): 66715-6405-2
ndc (package): 66715-6581-2
ndc (package): 66715-9905-2
ndc (product): 66715-9905
ndc (product): 66715-6581
ndc (product): 66715-6405
ndc11 (package): 66715990502
ndc11 (package): 66715658102
ndc11 (package): 66715640502
spl id: 06be9e28-b6c3-a4e4-e063-6294a90a3400
spl set id: e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b

Reported adverse events (FAERS/openFDA)#

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