Vicks Formula 44 Cough Drops

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-10-09 01:01:05

Label at a glance#

ProductVicks Formula 44 Cough Drops
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

temporarily relieves: cough associated with a cold occasional minor irritation or sore throat

Dosage and administration

adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 12 years of age: do not use

Storage and handling

Store at 20°- 25°C (68°-77°F) in a dry place Contains soy

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (per drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.8 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant/Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • cough associated with a cold
  • occasional minor irritation or sore throat

Warnings

WARNINGS SECTION

Sore Throat Warning:

SPL UNCLASSIFIED SECTION

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)
  • a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days

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.
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

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.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • Store at 20°- 25°C (68°-77°F) in a dry place
  • Contains soy

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, eucalyptus oil, FD&C Red No. 40, flavors, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-800-342-6844

SPL UNCLASSIFIED SECTION

DIST. BY
PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 50 Drop Bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

FORMULA 44™

COUGH DROPS

MENTHOL • Cough Suppressant / Oral Anesthetic

Cooling Menthol

Soothes Sore Throat

Relieves Cough

actual size

50 MEDICATED DROPS

997997

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900042162GTIN-13: 0323900042162
EAN-13: 0323900042162
GTIN-12: 323900042162
UPC-A: 323900042162
GTIN storage (14 digits): 00323900042162
997.jpg

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-99737000-997-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-12full-release2026-06-01 01:22:36
72025-10-24monthly-update2026-06-03 17:38:43
62024-10-10full-release2026-06-01 00:24:17

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 Formula 44 Cough DropsMENTHOLThe Procter & Gamble Manufacturing Companybb9e483e-095d-8a42-e053-2a95a90ad8d62025-12-12WarningsExact identifier
ndc (package): 37000-997-50
ndc (product): 37000-997
ndc11 (package): 37000099750
spl set id: bb9e483e-095d-8a42-e053-2a95a90ad8d6

Reported adverse events (FAERS/openFDA)#

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