VICKS

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-10-09 01:01:09

Label at a glance#

ProductVICKS FORMULA 44DM 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 useif 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)

809809

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900039162GTIN-13: 0323900039162
EAN-13: 0323900039162
GTIN-12: 323900039162
UPC-A: 323900039162
GTIN storage (14 digits): 00323900039162
809.jpg
Data codeData Matrix21389351809.jpg
Data codeData Matrix91004714809.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product 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 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-80969423-809-12

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-02full-release2026-06-01 01:19:02

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
44f8a667-905a-25b0-e063-6394a90a046d05411a51-a49a-96fd-e063-6294a90ae37b2025-12-02WarningsExact identifier
spl set id: 05411a51-a49a-96fd-e063-6294a90ae37b

Reported adverse events (FAERS/openFDA)#

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