Indications and uses
Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.
Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.
Adults and children 5 years and older: Allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor. Children under 5 years: Do not use.
Benzocaine 15 mg
Menthol 2.6 mg
Oral anesthetic
Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.
Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduced 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
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. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens, see your dentist or doctor promptly.
Do not use
Stop use and ask doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
Allergy alert : Do not use this product if you have a history of allergy to local anesthetic such as procaine, butacaine, benzocaine, or other "caine" anesthetics
Adults and children 5 years and older:
Allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
Children under 5 years: Do not use.
TEMPER EVIDENT PACKAGING. DO NOT USE IF OUTER BOX OR BLISTER IS OPENED OR DAMAGED.
Acesulfame k, Citric acid, Honey lime flavor, Liquid glucose, Sucrose, Tartaric acid, Tartrazine and Water
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83348-002-01 | 2024-07-30 | C162847 | 48780-1 | 1030e365-55c3-111a-e063-dadaa90a10e2 | fb997cec-3025-4ca4-bd9a-b0331b1a6a2a |
| 83348-002-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-55c3-111a-e063-dadaa90a10e2 | fb997cec-3025-4ca4-bd9a-b0331b1a6a2a |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83348-002-01 | Anesthetic Lozenges Honey Lime Flavors | 10 in 1 CARTON | LOZENGE | 10 | 1 | |
| 83348-002-01 | Anesthetic Lozenges Honey Lime Flavors | 9 in 1 BLISTER PACK | LOZENGE | 9 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83348-002 | 83348-002-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROSE, UNSPECIFIED FORM | IY9XDZ35W2 | IACT |
| SUCROSE | C151H8M554 | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
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 |
|---|---|---|---|---|---|---|
| fab61465-dfeb-0498-e053-6294a90a9aec | fb997cec-3025-4ca4-bd9a-b0331b1a6a2a | 2023-05-02 | Warnings | fab61465-dfeb-0498-e053-6294a90a9aec fb997cec-3025-4ca4-bd9a-b0331b1a6a2a |
Adverse event summaries are temporarily unavailable. Other product information remains available.