OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients (in each lozenge)
Benzocaine 15 mg
Menthol 3.6 mg
Drug Facts
Active ingredients (in each lozenge)
Benzocaine 15 mg
Menthol 3.6 mg
Purposes
Oral pain reliever
Oral pain reliever
Uses
For the temporary relief of occasional
■ sore throat ■ sore mouth ■ minor irritation ■ pain
■ pain associated with canker sores
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
■ pale, gray, or blue colored skin (cyanosis)
■ headache
■ rapid heart rate
■ shortness of breath
■ dizziness or lightheadedness
■ fatigue or lack of energy
Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.
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.
Stop use and ask a doctor or dentist if
■ sore mouth symptoms do not improve in 7 days
■ irritation, pain, or redness persists or worsens
■ swelling, rash, or fever develops
If pregnant or breast-feeding, ask a health professional before use.
Do not use
■ for teething
■ in children under 5 years of age
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not exceed recommended dosage
Directions
■ adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
■ children under 5 years of age: do not use
Other Information:
■ store at 20-25°C (68-77°F)
■ protect contents from humidity
Inactive Ingredients:
FD&C red no. 40, Flavor, Isomalt, Maltitol, Sodium bicarbonate, Sucralose
Questions?
Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 44237-045 | 44237-045-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| ISOMALT | S870P55O2W | IACT |
| MALTITOL | D65DG142WK | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| FD&C RED NO. 40 | WZB9127XOA | 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 |
|---|---|---|---|---|---|---|
| c1871746-5d7d-455e-ab45-2f16ee49481a | 4bf2f456-7a34-4b20-9138-b47f84603e09 | 2021-07-28 | Warnings | 4bf2f456-7a34-4b20-9138-b47f84603e09 |
Adverse event summaries are temporarily unavailable. Other product information remains available.