OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each lozenge) - Menthol 8.6mg
Active Ingredient (in each lozenge) - Menthol 8.6mg
Cough suppressant / Oral Anesthetic
Uses: temporarily relieves • cough as may occur with a cold • occasional minor irritation and sore throat
Warnings:
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These smptoms may be serious.
Ask a doctor before use if you have: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)
Stop use and consult a doctor if:
• cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
• sore throat is severe, or irritation, pain or redness lasts or worsens
• sore mouth does not improve in 7 days
If pregnant or breast-feeding baby, ask a health professional before use.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions:
• Adults and children 5 years and older: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor.
• Children under 5 years: Consult a doctor.
corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67060-121-74 | 2023-01-30 | C162847 | 48780-1 | f386c649-bcc4-0266-e053-dadaa90a7c1a | 2e83f15b-fa5e-4e5c-b43c-abab308205a2 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67060-121-01 | ADVANCED HONEY LEMON COUGH DROPS | 1 in 1 PACKET | LOZENGE | 1 | 1 | |
| 67060-121-74 | ADVANCED HONEY LEMON COUGH DROPS | 100 in 1 CARTON | LOZENGE | 100 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67060-121 | 67060-121-01, 67060-121-74 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HONEY | Y9H1V576FH | IACT |
| LEMON OIL | I9GRO824LL | IACT |
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 |
|---|---|---|---|---|---|---|
| c5a88d98-b8fb-4a84-b6ad-3f39f142b23f | 2e83f15b-fa5e-4e5c-b43c-abab308205a2 | 2019-08-07 | Warnings | c5a88d98-b8fb-4a84-b6ad-3f39f142b23f 2e83f15b-fa5e-4e5c-b43c-abab308205a2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.