LEGEND COUGH lozenge

Manufacturer
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
Effective date
2020-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:14

Label at a glance#

ProductLEGEND COUGH lozenge
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporarily suppresses/relieves: Coughs due to minor throat and bronchial irritation from a cold or inhaled irritant Occasional minor sore throat pain

Dosage and administration

Dissolve a lozenge slowly in mouth. May be repeated every hour for coughs as needed or as directed by a doctor. May be repeated every 2 hours for sore throat. Do not take more than 10 lozenges per day.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol

Purpose

OTC - PURPOSE SECTION

Cough Suppressant/ Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily suppresses/relieves:

  • Coughs due to minor throat and bronchial irritation from a cold or inhaled irritant
  • Occasional minor sore throat pain

Warnings

WARNINGS SECTION


Ask a doctor before use if you have

  • Chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
  • Cough that occurs with too much phlegm (mucus)

When using this product

Do not use more than directed, taking more may have a laxative effect

Stop use and ask a doctor if

  • Cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts.These could be signs of a serious condition
  • Sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
  • Sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dissolve a lozenge slowly in mouth.
  • May be repeated every hour for coughs as needed or as directed by a doctor.
  • May be repeated every 2 hours for sore throat.
  • Do not take more than 10 lozenges per day.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Adults and children 6 years and older 10 mg
  • Children under 6 years ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Honey powder, Ginger extract, Licorice extract, Eucalyptol oil, Mexican Mint oil, Cinnamon oil, Mannitol, Sorbitol, Povidone K30, Xylitol, Silicone Dioxide, Magnesium stearate, Aspartame, Sucralose, Sodium benzoate, FD&C Yellow No. 5, FD&C Blue No. 1

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199393menthol 10 MG Oral LozengePSN1
199393menthol 10 MG Oral LozengeSCD1
199393menthol 10 MG Oral PastilleSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-842-242022-01-28C16284748780-1d6a99b39-a516-a426-e053-dadaa90af4c2LEGEND

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-842-24LEGEND COUGH lozenge24 in 1 BOXLOZENGE241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-842LEGEND COUGH LOZENGE (MENTHOL) LOZENGE [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 1 package rows20200501_b56b8338-184b-4a65-85ab-7491b4b0c4fe.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13411-84213411-842-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML · Source PDF

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
69f6297d-0aa8-4719-a0e4-9b166aff8230b56b8338-184b-4a65-85ab-7491b4b0c4fe2020-04-15WarningsExact identifier
spl id: 69f6297d-0aa8-4719-a0e4-9b166aff8230
spl set id: b56b8338-184b-4a65-85ab-7491b4b0c4fe

Reported adverse events (FAERS/openFDA)#

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