Storage and handling
Dry, avoid sunlight
Cough Drops
- Manufacturer
- Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.
- Effective date
- 2023-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-05-31 23:57:37
Label at a glance#
ProductCough Drops
Active ingredientMENTHOL
Label structure14 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Cough Drops
OTC - ACTIVE INGREDIENT SECTION
Menthol
OTC - PURPOSE SECTION
cough suppressant, oral anesthetic
INDICATIONS & USAGE SECTION
temporarily relieves: cough due to cold, occasional minor irritation or sore throat
WARNINGS SECTION
Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. 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).
Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,
or is accompained by fever, rash, or persistent headache. These could be signs of a
serious condition. sore mouth does not improve in 7 days
irritation, pain, or redness persists or worsens.
OTC - WHEN USING SECTION
adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.
children under 5 years: ask a doctor.
OTC - STOP USE SECTION
Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,
or is accompained by fever, rash, or persistent headache. These could be signs 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. Repeatevery 2 hours as needed.
children under 5 years: ask a doctor.
STORAGE AND HANDLING SECTION
Dry, avoid sunlight
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
RECENT MAJOR CHANGES SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 80404-501-01 | 2024-07-30 | C162847 | 48780-1 | 1030e365-06f0-111a-e063-dadaa90a10e2 | Cough Drops |
| 80404-501-02 | 2024-07-30 | C162847 | 48780-1 | 1030e365-06f0-111a-e063-dadaa90a10e2 | Cough Drops |
| 80404-501-03 | 2024-07-30 | C162847 | 48780-1 | 1030e365-06f0-111a-e063-dadaa90a10e2 | Cough Drops |
| 80404-501-04 | 2024-07-30 | C162847 | 48780-1 | 1030e365-06f0-111a-e063-dadaa90a10e2 | Cough Drops |
| 80404-501-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-06f0-111a-e063-dadaa90a10e2 | Cough Drops |
| 80404-501-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-06f0-111a-e063-dadaa90a10e2 | Cough Drops |
| 80404-501-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-06f0-111a-e063-dadaa90a10e2 | Cough Drops |
| 80404-501-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-06f0-111a-e063-dadaa90a10e2 | Cough Drops |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80404-501-01 | Cough Drops | 25 in 1 BAG | TABLET, ORALLY DISINTEGRATING | 25 | 10 | |
| 80404-501-02 | Cough Drops | 30 in 1 BAG | TABLET, ORALLY DISINTEGRATING | 30 | 10 | |
| 80404-501-03 | Cough Drops | 70 in 1 BAG | TABLET, ORALLY DISINTEGRATING | 70 | 10 | |
| 80404-501-04 | Cough Drops | 80 in 1 BAG | TABLET, ORALLY DISINTEGRATING | 80 | 10 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cough Drops
- MENTHOL
- WATER
- CITRIC ACID MONOHYDRATE
- EUCALYPTUS OIL
- FD&C BLUE NO. 1
- CORN SYRUP
- POTASSIUM CITRATE
- LECITHIN, SOYBEAN
- FD&C RED NO. 40
- SUCRALOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80404-501 | 80404-501-01, 80404-501-02, 80404-501-03, 80404-501-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| POTASSIUM CITRATE | EE90ONI6FF | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 086d83fb-1341-42f9-e063-6294a90a900e | ff3fa2fa-6741-fa43-e053-6294a90a5d5b | 2023-10-23 | Warnings | 086d83fb-1341-42f9-e063-6294a90a900e ff3fa2fa-6741-fa43-e053-6294a90a5d5b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.