Meyer Lemon and Honey-Cough Relief Lozenges (Oral Anesthetic)

Manufacturer
Quantum, Inc. | Primrose Candy Company
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:02

Label at a glance#

ProductMeyer Lemon and Honey-Cough Relief Lozenges (Oral Anesthetic)
Active ingredientMENTHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

(In each lozenge)

Organic Menthol 5mg

OTC - PURPOSE SECTION

Antitussive (Cough Suppressant) / Oral Anesthetic

WARNINGS SECTION

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by a physician.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you have:

- persistent or chronic cough as occurs with smoking, asthma, or emphysema.

- cough that occurs with excessive phlegm (mucus).

OTC - STOP USE SECTION

- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

- sore mouth symptoms do 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 out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. Children under 5years of age: ask a doctor.

OTHER SAFETY INFORMATION

Store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Organic Brown Rice Syrup, Organic Cane Syrup, Organic Honey, Natural Meyer Lemon Flavor and Other Natural Flavors, Organic Slippery Elm Bark Powder, and Organic Tumeric.

INDICATIONS & USAGE SECTION

- cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritation,

- occasional minor irritation, pain, sore mouth, and sore throat.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311508menthol 5 MG Oral LozengePSN2
311508menthol 5 MG Oral LozengeSCD2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70084-614-012025-01-30C16284748780-12cef2736-a64f-d83d-e063-dadaa90ab31fMeyer Lemon and Honey-Cough Relief Lozenges (Oral Anesthetic)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70084-614-01Meyer Lemon and Honey-Cough Relief Lozenges (Oral Anesthetic)18 in 1 BOXLOZENGE182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70084-614MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC) (MENTHOL) LOZENGE [QUANTUM, INC.]2Legacy NDC, 1 package rows20230111_99847797-99e9-40d4-e053-2995a90a972a.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70084-61470084-614-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
f1ec79eb-d3b9-628e-e053-2a95a90a02ac99847797-99e9-40d4-e053-2995a90a972a2023-01-10WarningsExact identifier
spl id: f1ec79eb-d3b9-628e-e053-2a95a90a02ac
spl set id: 99847797-99e9-40d4-e053-2995a90a972a

Reported adverse events (FAERS/openFDA)#

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