FDA.reportPublic FDA data

Vicks VapoDrops

Manufacturer
Procter & Gamble Manufactura S de RL de CV
Effective date
2023-10-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:24:02

Label at a glance#

ProductVicks VapoDrops Cough Relief
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 & children 5 yrs. & older dissolve 3 drops (one at a time) slowly in the mouth children 2 to under 5 yrs. ask a doctor children under 2 yrs. do not use Repeat every 2 hours as needed or as directed by a doctor.

Storage and handling

Do not exceed 25°C contains soy

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (per drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.7 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 5 years of age unless directed by doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • 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. These could be signs of a serious condition.
  • 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 & children 5 yrs. & olderdissolve 3 drops (one at a time) slowly in the mouth
children 2 to under 5 yrs.ask a doctor
children under 2 yrs.do not use

Repeat every 2 hours as needed or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Do not exceed 25°C
  • contains soy

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, corn syrup, eucalyptus oil, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-800-707-1709

SPL UNCLASSIFIED SECTION

DIST. BY:

PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 20 Drops

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

VapoDrops ™

COUGH RELIEF

CHERRY FLAVOR

Menthol Cough Suppressant/ Oral Anesthetic

20 Drops

679679

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58933-679-202021-06-10C16284748780-1ba0f9c33-379b-a910-e053-dadaa90a0b85Vicks ® VapoDrops ™ Cough Relief
58933-679-202021-01-29C16284748780-1ba0f9c33-379b-a910-e053-dadaa90a0b85Vicks ® VapoDrops ™ Cough Relief

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58933-67958933-679-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUCALYPTUS OIL2R04ONI662IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
SUCROSEC151H8M554IACT
MENTHOLL7T10EIP3AACTIB

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
07e9a63f-641a-7a5e-e063-6394a90a1f546998350b-5381-7e61-e053-2a91aa0adb202023-10-17WarningsExact identifier
spl id: 07e9a63f-641a-7a5e-e063-6394a90a1f54
spl set id: 6998350b-5381-7e61-e053-2a91aa0adb20

Reported adverse events (FAERS/openFDA)#

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