FDA.reportPublic FDA data

VICKS

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-07 01:02:04

Label at a glance#

ProductVicks NyQuil ALLERGY
Active ingredientDOXYLAMINE SUCCINATE
Label structure16 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

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 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Storage and handling

each 15 mL contains: sodium 15 mg Store at no greater than 25°C (77ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem that lasts or occurs with chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OVERDOSAGE 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 & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 15 mg
  • Store at no greater than 25°C (77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND ON BOTTLE IS BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®NyQuil™

ALLERGY

Doxylamine Succinate

- Antihistamine

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat and Nose

Alcohol Free

12 FL OZ (354 mL)

346346

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900038905GTIN-13: 0323900038905
EAN-13: 0323900038905
GTIN-12: 323900038905
UPC-A: 323900038905
GTIN storage (14 digits): 00323900038905		346.jpg
Data codeData Matrix21238666346.jpg
Data codeData Matrix21243533346.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-34684126-346-12, 84126-346-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-06-22monthly-update2026-07-17 21:35:11
32025-03-07full-release2026-06-01 01:06:02

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
Vicks NyQuil ALLERGYDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2f9b3bbb-4494-065d-e063-6294a90afcd22026-06-22WarningsExact identifier
ndc (package): 84126-346-24
ndc (package): 84126-346-12
ndc (product): 84126-346
ndc11 (package): 84126034612
ndc11 (package): 84126034624
spl set id: 2f9b3bbb-4494-065d-e063-6294a90afcd2

Reported adverse events (FAERS/openFDA)#

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