OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each drop)
Menthol 5.8 mg
Active ingredient (in each drop)
Menthol 5.8 mg
Purpose
Cough suppressant/
Oral anesthetic
Uses temporarily relieves:
cough as may occur with a cold or inhaled irritants
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 symptoms may be serious.
Ask a doctor before use if you have:
persistent or chronic cough such as occurs with smoking, ashtma, or emphysema
cough accompanied by excessive phlegm (mucus)
When using this product
do not exceed recommended dosage
Stop use and consult 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, ask a health professional before use.
Keep this and all drugs out of the reach of children
Directions
Adults and children 5 years and over allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by doctor.
children under 5 years ask a doctor
Other information
6 calories per drop
Excess consumption may cause laxative effect.
Inactive ingredients: acesulfame potassium, eucalyptus oil, FD&C Blue #1, FD&C Red #40, flavoring, gum arabic, hydrogenated starch hydrolysate, isomalt, sucralose, and water. Soybean oil used as processing aid.
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55316-024 | 55316-024-25 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 7927b746-c413-36b0-e053-2991aa0aaf6e | 4a172655-5bb2-36f0-e054-00144ff88e88 | 2018-10-26 | Warnings | 7927b746-c413-36b0-e053-2991aa0aaf6e 4a172655-5bb2-36f0-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.