NICE Citrus Cough Drops

Manufacturer
Leosons Overseas Corp
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:06

Label at a glance#

ProductNICE Citrus Cough Drops
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

temporarily suppresses / relieves: coughs due to minor throat and bronchial irritation from a cold or inhaled irritants 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 adults and children 6 years and older 5 mg children under 6 years ask a doctor

Label contents#

Full prescribing information#

Active ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each lozenge)

Menthol 5 mg

OTC - PURPOSE SECTION

Active ingredient (in each lozenge)

Purposes
Menthol 5 mg .....Cough Suppressant / Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily suppresses / relieves:

  • coughs due to minor throat and bronchial irritation from a cold or inhaled irritants
  • occasional minor sore throat pain

Warnings

WARNINGS SECTION

Warnings

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)

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

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

Stop use and ask doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signes 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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
adults and children 6 years and older 5 mg
children under 6 years ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame Potassium, Citric Acid, D&C Yellow No. 10, Eucalyptus Oil, Isomalt, Lemon Oil, Other Natural and Artificial Flavors, Sodium Citrate

Questions?

OTC - QUESTIONS SECTION

Call 1-855-452-9500 or email at info@leosonsintl.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NICE Citrus 24ct Cough DropsNICE Citrus 24ct Cough Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311508menthol 5 MG Oral LozengePSN3
802773N'ICE 5 MG Oral LozengePSN3
802773menthol 5 MG Oral Lozenge [N'ICE]SBD3
311508menthol 5 MG Oral LozengeSCD3
802773N Ice 5 MG Oral LozengeSY3
802773N'Ice 5 MG Oral LozengeSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0044-4NICE Citrus Cough Drops24 in 1 BLISTER PACKLOZENGE243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0044NICE CITRUS COUGH DROPS (MENTHOL) LOZENGE [LEOSONS OVERSEAS CORP]3Current NDC, Legacy NDC, 1 package rows20241121_96d9527d-9bf9-ce82-e053-2995a90aff0c.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
69626-004469626-0044-4

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
NICE Citrus Cough DropsMENTHOLLeosons Overseas Corp96d9527d-9bf9-ce82-e053-2995a90aff0c2024-11-19WarningsExact identifier
ndc (package): 69626-0044-4
ndc (product): 69626-0044
ndc11 (package): 69626004404
spl id: 2747630c-6f58-a0fc-e063-6394a90ae659
spl set id: 96d9527d-9bf9-ce82-e053-2995a90aff0c

Reported adverse events (FAERS/openFDA)#

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