FDA.reportPublic FDA data

NICE Assorted Cough Drops

Manufacturer
Leosons Overseas Corp
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:06

Label at a glance#

ProductNICE Assorted 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 a 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 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

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 older5 mg
children under 6 years ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame Potassium, Ascorbic Acid*, Caramel Color*, D&C Yellow No. 10*, Eucalyptus Oil, FD&C Blue No. 1*, FD&C Red No. 40*, FD&C Yellow No. 6*, Isomalt, Natural and Artificial Flavors, Sodium Citrate*, Tartaric Acid*

*may contain one or more of these ingredients

Questions?

OTC - QUESTIONS SECTION

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NICE Assorted 24ct Cough DropsNICE Assorted 24ct Cough Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311508menthol 5 MG Oral LozengePSN4
802773N'ICE 5 MG Oral LozengePSN4
802773menthol 5 MG Oral Lozenge [N'ICE]SBD4
311508menthol 5 MG Oral LozengeSCD4
802773N Ice 5 MG Oral LozengeSY4
802773N'Ice 5 MG Oral LozengeSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0046-4NICE Assorted Cough Drops24 in 1 BLISTER PACKLOZENGE244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0046NICE ASSORTED COUGH DROPS (MENTHOL) LOZENGE [LEOSONS OVERSEAS CORP]4Current NDC, Legacy NDC, 1 package rows20241121_96db0f37-41cc-1ebd-e053-2a95a90a3215.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69626-004669626-0046-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARAMELT9D99G2B1RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
EUCALYPTUS OIL2R04ONI662IACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
MENTHOLL7T10EIP3AACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
ISOMALTS870P55O2WIACT
TARTARIC ACIDW4888I119HIACT
SODIUM CITRATE1Q73Q2JULRIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 Assorted Cough DropsMENTHOLLeosons Overseas Corp96db0f37-41cc-1ebd-e053-2a95a90a32152024-11-19WarningsExact identifier
ndc (package): 69626-0046-4
ndc (product): 69626-0046
ndc11 (package): 69626004604
spl id: 274730dd-05c1-3b7c-e063-6394a90ab4cd
spl set id: 96db0f37-41cc-1ebd-e053-2a95a90a3215

Reported adverse events (FAERS/openFDA)#

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