FDA.reportPublic FDA data

Vicks

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2022-10-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:51:50

Label at a glance#

ProductVicks Formula 44 Cough and Head Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

take only as directed use the dose cup provided do not exceed 4 doses per 24 hours adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use

Storage and handling

each tablespoon contains: sodium 45 mg store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 15 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Nasal decongestant

Use

INDICATIONS & USAGE SECTION

temporarily relieves common cold symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

When using this product, do not use more than directed.

OTC - ASK DOCTOR SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • nasal congestion or cough persist for more than one week or are accompanied by fever
  • cough comes back, or occurs with fever, 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • use the dose cup provided
  • do not exceed 4 doses per 24 hours

adults and children 12 years and over 30 mL every 4 hours

children 6 to under 12 years 15 mL every 4 hours

children 4 to under 6 years ask a doctor

children under 4 years do not use

Other information

STORAGE AND HANDLING SECTION

  • each tablespoon contains: sodium 45 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, 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

DIST. BY PROCTER&GAMBLE,

CINCINNATI OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

FORMULA

44™

ATTACKS COUGH AT THE SOURCE

FAST

RELIEF

COUGH &

HEAD CONGESTION

Phenylephrine HCl :
nasal decongestant

Dextromethorphan HBr :

cough suppressant

Non-Drowsy

BERRY FLAVOR

NEW


12 FL OZ (354 ml)

449449

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-44937000-449-12

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
SODIUM CHLORIDE451W47IQ8XIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE1Q73Q2JULRIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SORBITOL506T60A25RIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
SODIUM BENZOATEOJ245FE5EUIACT

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
eb53cf21-3170-43be-e053-2995a90ab63d4ea0c6cd-5920-39fc-e054-00144ff88e882022-10-18WarningsExact identifier
spl set id: 4ea0c6cd-5920-39fc-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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