Cough Drops

Manufacturer
Perrigo Direct, Inc. | Boston Nutraceutical Science SL | Boston Nutraceutical Production SL
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:23:09

Label at a glance#

ProductCough Drops
Active ingredientMENTHOL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

  • Menthol 5.4 mg cough suppresant oral anesthetic Front PanelFront Panel

OTC - PURPOSE SECTION

Uses temporarily relieves:

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat

INDICATIONS & USAGE SECTION

Uses temporarily relieves:

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat

WARNINGS SECTION

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a severe throat accompanied by difficulty in breathing or that last more than 2 days
  • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

OTC - STOP USE SECTION

Stop use and consult a doctor if

  • sore mouth symptons do not improve in 7 days or if irritation, pains 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 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 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 12 years and under do not use

OTHER SAFETY INFORMATION

  • Store in a cool and dry place
  • 10 calories per drop

INACTIVE INGREDIENT SECTION

  • glucose syrup, sucrose

Back PanelBack Panel

OTC - QUESTIONS SECTION

Questions or comments: 1-855-423-2630

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BackBack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
485287menthol 5.4 MG Oral LozengePSN2
485287menthol 5.4 MG Oral LozengeSCD2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-592-01Cough Drops30 in 1 BAGPASTILLE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-592COUGH DROPS (SIMPLY MENTHOL COUGH DROPS) PASTILLE [PERRIGO DIRECT, INC.]2Current NDC, 1 package rows20241009_fb809c63-94f1-bb7a-e053-6294a90a0a39.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-592-01EA - Each50804-592e350ebf9-6b05-4f5b-9e20-3367e890690512024-03-12

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
50804-59250804-592-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN SYRUP9G5L16BK6NIACT
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
Cough DropsSIMPLY MENTHOL COUGH DROPSPerrigo Direct, Inc.fb809c63-94f1-bb7a-e053-6294a90a0a392024-10-07WarningsExact identifier
ndc (package): 50804-592-01
ndc (product): 50804-592
ndc11 (package): 50804059201
spl id: 23e56dcd-0df6-fdce-e063-6294a90ae81d
spl set id: fb809c63-94f1-bb7a-e053-6294a90a0a39

Reported adverse events (FAERS/openFDA)#

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