Cough Drops

Manufacturer
Xiamen Misero Biotechnology Co, Ltd
Effective date
2024-07-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:16:12

Label at a glance#

ProductCough Drops
Active ingredientMENTHOL
Label structure13 sections

Storage and handling

Store in a cool place.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Cough Drops

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 0.18%

OTC - PURPOSE SECTION

cough suppressant, oral anesthetic

INDICATIONS & USAGE SECTION

temporarily relieves:
cough due to cold
occasiona! minor irritation or sore throat

WARNINGS SECTION

Sore throat warninq: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorpromptly. These may be serious.

OTC - DO NOT USE SECTION

Ask a doctor before use if you have:
persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
cough accompanied by excessive phlegm (mucus).

OTC - WHEN USING SECTION

Ask a doctor before use if you have:
persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
cough accompanied by excessive phlegm (mucus).

OTC - STOP USE SECTION

cough persists for more than 1 week, tends to recur,or is accompained by tever, rash, or persistent headache. These could be sions of a serious condition.
sore mouth does not improve in 7 days.
irritation, pain, or redness persists or worsens.

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 1 drop slowly in the mouth. Repeat every 2 hours as needed.
children under 5 years: ask a doctor.

STORAGE AND HANDLING SECTION

Store in a cool place.

INACTIVE INGREDIENT SECTION

EUCALYPTUS OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM CITRATE
SOY LECITHIN
SUCRALOSE
SUCROSE
GLUCOSE SYRUP
CITRIC ACID
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84236-101COUGH DROPS (MENTHOL) TABLET, ORALLY DISINTEGRATING [XIAMEN MISERO BIOTECHNOLOGY CO, LTD]3Unmatched20240731_157dbd99-1bff-c2c5-e063-6394a90ac031.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84236-10184236-101-01, 84236-101-02, 84236-101-03, 84236-101-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
41353708-0f35-5971-e063-6294a90a9752157dbd99-1bff-c2c5-e063-6394a90ac0312025-10-15WarningsExact identifier
spl set id: 157dbd99-1bff-c2c5-e063-6394a90ac031

Reported adverse events (FAERS/openFDA)#

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