Menthol

Manufacturer
McKesson | Pharmaloz Manufacturing, Inc. | Prestige Packaging
Effective date
2024-10-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:24:16

Label at a glance#

ProductMenthol
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each drop)

Menthol 7.6 mg

OTC - PURPOSE SECTION

Purpose

Antitussive (cough suppressant)/oral anesthetic

INDICATIONS & USAGE SECTION

Uses
Temporarily relieves

  • cough as may occur with a cold or inhaled irritants
  • occasional minor irritation and sore throat

WARNINGS SECTION

Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.
Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 does not improve in 7 days
  • irritation, pain, or redness persists or worsens

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use more than directed

Adults and children: (12 years and older)

  • Allow 1 drop to dissolve slowly in the mouth.
  • May be repeated every 2 hours as necessary or as directed by a doctor.

Children under 12 years:
Do not give to children under 12 years of age.

OTHER SAFETY INFORMATION

Other information

  • 15 calories per drop
  • store at 59º-86ºF (15º-30ºC)
  • protect from moisture & heat

INACTIVE INGREDIENT SECTION

Inactive ingredients:
cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose

OTC - QUESTIONS SECTION

Questions?1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

27996M27996MNDC 68599-0464-9

McKesson

Cough Drops

Menthol Eucalyptus

250 per Jar

MFR# 27996M

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68599-0464-92022-10-24C16284748780-1d6a99b39-4d89-a426-e053-dadaa90af4c2Menthol Eucalyptus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0464-9Menthol0.7 g in 1 JARLOZENGE0.78

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0464MENTHOL (COUGH SUPPRESSANT) LOZENGE [MCKESSON]8Current NDC, Legacy NDC, 1 package rows20241012_9d4def70-480f-f2fa-e053-2995a90a9877.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-046468599-0464-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
MentholCOUGH SUPPRESSANTMcKesson9d4def70-480f-f2fa-e053-2995a90a98772024-10-10WarningsExact identifier
ndc (package): 68599-0464-9
ndc (product): 68599-0464
ndc11 (package): 68599046409
spl id: 24241327-4250-104a-e063-6294a90a41e7
spl set id: 9d4def70-480f-f2fa-e053-2995a90a9877

Reported adverse events (FAERS/openFDA)#

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