ADVANCED HONEY LEMON COUGH DROPS

Manufacturer
ADVANCED FIRST AID, INC. | ULTRA SEAL CORPORATION | Pharmaloz Manufacturing, Inc.
Effective date
2019-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:26

Label at a glance#

ProductADVANCED HONEY LEMON COUGH DROPS
Active ingredientMENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each lozenge) - Menthol 8.6mg

OTC - PURPOSE SECTION

Cough suppressant / Oral Anesthetic

INDICATIONS & USAGE SECTION

Uses: temporarily relieves • cough as may occur with a cold • 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, swelling, nausea, or vomiting, consult a doctor promptly. These smptoms may be serious.

Ask a doctor before use if you have: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

Stop use and consult a 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 lasts or worsens

• sore mouth does not improve in 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. 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 older: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor.

• Children under 5 years: Consult a doctor.

INACTIVE INGREDIENT SECTION

corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HONEY LEMON COUGH DROPS 100ct CARTONHONEY LEMON COUGH DROPS 100ct CARTONHONEY LEMON COUGH DROPS 100ct CARTONHONEY LEMON COUGH DROPS 100ct CARTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
433194menthol 8.6 MG Oral LozengePSN1
433194menthol 8.6 MG Oral LozengeSCD1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67060-121-742023-01-30C16284748780-1f386c649-bcc4-0266-e053-dadaa90a7c1a2e83f15b-fa5e-4e5c-b43c-abab308205a2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67060-121-01ADVANCED HONEY LEMON COUGH DROPS1 in 1 PACKETLOZENGE11
67060-121-74ADVANCED HONEY LEMON COUGH DROPS100 in 1 CARTONLOZENGE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67060-121ADVANCED HONEY LEMON COUGH DROPS (COUGH DROPS) LOZENGE [ADVANCED FIRST AID, INC.]1Legacy NDC, 2 package rows20190917_2e83f15b-fa5e-4e5c-b43c-abab308205a2.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67060-12167060-121-01, 67060-121-74

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
c5a88d98-b8fb-4a84-b6ad-3f39f142b23f2e83f15b-fa5e-4e5c-b43c-abab308205a22019-08-07WarningsExact identifier
spl id: c5a88d98-b8fb-4a84-b6ad-3f39f142b23f
spl set id: 2e83f15b-fa5e-4e5c-b43c-abab308205a2

Reported adverse events (FAERS/openFDA)#

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