FDA.reportPublic FDA data

Vicks Alcohol Free NyQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2022-10-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:50:07

Label at a glance#

ProductVicks Alcohol Free NyQuil Cold and Flu Nighttime Relief
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing

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 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

each 30 mL dose cup contains: sodium 25 mg store at no greater than 25°C and do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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

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
  • 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

  • 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

  • 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.

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.

Overdose warning

SPL UNCLASSIFIED SECTION

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
  • 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 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose cup contains: sodium 25 mg
  • store at no greater than 25°C and do not refrigerate

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

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

Alcohol Free

NyQuil™

COLD & FLU

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose

Cough

12 FL OZ (354 ml)

Nighttime Relief

Alcohol Free

699699

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-699-082021-02-11C16284748780-1ba0f9c33-5b4a-a910-e053-dadaa90a0b85VICKS ® Alcohol Free NyQuil ® COLD & FLU
37000-699-122021-02-11C16284748780-1ba0f9c33-5b4a-a910-e053-dadaa90a0b85VICKS ® Alcohol Free NyQuil ® COLD & FLU
37000-699-082021-01-29C16284748780-1ba0f9c33-5b4a-a910-e053-dadaa90a0b85VICKS ® Alcohol Free NyQuil ® COLD & FLU
37000-699-122021-01-29C16284748780-1ba0f9c33-5b4a-a910-e053-dadaa90a0b85VICKS ® Alcohol Free NyQuil ® COLD & FLU

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-699-12ML - Milliliter37000-699ce60c83c-7223-4638-aa06-3f1cd8aaae0a12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D3
Chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9Z3
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH3
AcetaminophenACTIVE MOIETY362O9ITL9D3
ChlorpheniramineACTIVE MOIETY3U6IO1965U3
DextromethorphanACTIVE MOIETY7355X3ROTS3
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G93
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS3113
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA3
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6S3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A3
propylene glycolINACTIVE INGREDIENT6DC9Q167V33
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU3
sodium citrateINACTIVE INGREDIENT1Q73Q2JULR3
waterINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-69937000-699-08, 37000-699-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 330 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRACARDIAC1.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii candidate
28 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311AEROSOL, FOAM / VAGINAL0.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE, FOR SUSPENSION / ORAL15.63 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / BUCCAL4 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9SOLUTION / DENTAL0.12 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9SUSPENSION / ORAL160 mgExact identifier — unii candidate
17 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii candidate
44 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
17 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE / ORAL160 mgExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii candidate
17 equally ranked IID candidates

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
ec57f4b5-a766-2784-e053-2995a90a8f410fe37f2e-cf13-451d-8988-e96a5712e3592022-10-31WarningsExact identifier
spl id: ec57f4b5-a766-2784-e053-2995a90a8f41
spl set id: 0fe37f2e-cf13-451d-8988-e96a5712e359

Reported adverse events (FAERS/openFDA)#

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