Menthol Cough Drops

Manufacturer
Boston Nutraceutical Production SL | Boston Nutraceutical Science SL
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:23:04

Label at a glance#

ProductMenthol Cough Drops
Active ingredientMENTHOL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient in each drop Purposes

Menthol 5.8 mg

Cough Suppressant

Oral anesthetic

Front labelFront label

OTC - PURPOSE SECTION

Purposes

Cough suppressant/

Oral anesthetic

INDICATIONS & USAGE SECTION

Uses Temporarily relieves:

  • cough as may occur with cold or inhaled irritants
  • ocassional minor irritations 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, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

cough accompanied by excessvie phlegm (mucus)

OTC - STOP USE SECTION

Stop use and consult doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness last or worsens
  • sore mouth does not improve in 7 days

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 this and all drugs out of the reach of children.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 5 years and over: allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
  • Children under 5 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

  • 6 calories per drop
  • May be useful for diabetics on the advise of a doctor
  • Excessive consumption may cause laxative effect

INACTIVE INGREDIENT SECTION

Isomalt, stevia, water

BackBack

OTC - QUESTIONS SECTION

Questions or comments call: 617-848-4560

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FrontFront

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
476973menthol 5.8 MG Oral LozengePSN3
476973menthol 5.8 MG Oral LozengeSCD3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72628-105-01Menthol Cough Drops36 in 1 BAGPASTILLE363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72628-105MENTHOL COUGH DROPS (MENTHOL) PASTILLE [BOSTON NUTRACEUTICAL PRODUCTION SL]3Current NDC, Legacy NDC, 1 package rows20241009_857363b6-e025-e074-e053-2a91aa0a4379.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72628-10572628-105-01

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
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857363b6-e025-e074-e053-2a91aa0a43792024-10-07WarningsExact identifier
ndc (package): 72628-105-01
ndc (product): 72628-105
ndc11 (package): 72628010501
spl id: 23e6326b-0545-6032-e063-6394a90ab0aa
spl set id: 857363b6-e025-e074-e053-2a91aa0a4379

Reported adverse events (FAERS/openFDA)#

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