Vicks

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-08-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:27:06

Label at a glance#

ProductVicks Formula 44 Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure17 sections

Dosage and administration

take only as directed only use the dose cup provided do not exceed 4 doses per 24 hours adults and children 12 years and over 30 mL every 6-8 hours children 6 to under 12 years 15 mL every 6-8 hours children 4 to under 6 years ask a doctor children under 4 years do not use

Storage and handling

• each 15 mL contains: sodium 12 mg • store at no greater than 25°C • does not meet USP requirements for light resistant packaging

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 15 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Use

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

Warnings

WARNINGS 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

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours
adults and children 12 years and over30 mL every 6-8 hours
children 6 to under 12 years15 mL every 6-8 hours
children 4 to under 6 years

ask a doctor

children under 4 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

• each 15 mL contains:sodium 12 mg
• store at no greater than 25°C
• does not meet USP requirements for light resistant packaging

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

TAMPER EVIDENT: Do not use if printed shrinkband 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®

FORMULA

44™ DM

COUGH

Dextromethorphan HBr - cough suppressant

ATTACKS COUGH AT THE SOURCE

Non-Drowsy

12 FL OZ (354 ml)

447447

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-447-122022-10-11C16284748780-1d6a99b39-3737-a426-e053-dadaa90af4c2VICKS ® FORMULA 44™DM COUGH Liquid
37000-447-122022-01-28C16284748780-1d6a99b39-3737-a426-e053-dadaa90af4c2VICKS ® FORMULA 44™DM COUGH Liquid

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
37000-44737000-447-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
054566bd-d32c-e307-e063-6294a90acbee4e76fd19-8f11-683a-e054-00144ff8d46c2023-09-13WarningsExact identifier
spl set id: 4e76fd19-8f11-683a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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