Honey Lemon Sore Throat Lozenges
- Manufacturer
- Grandall Distributing | Bestco Inc.
- Effective date
- 2023-10-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:23:23
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each lozenge)
Benzocaine 15 mg
Menthol 2.6 mg
OTC - PURPOSE SECTION
Purpose
Oral anesthetic
Oral anesthetic
INDICATIONS & USAGE SECTION
Uses temporarily relieves these symptoms:
occasional minor irritation, pain, sore mouth and sore throat
WARNINGS SECTION
Warnings
Methemoglobinemia warning:
Use of this produce may cause methemoglobinemia, a serious conditionthat must be treated promptly because it reduces the amount of oxygen 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
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.
OTHER SAFETY INFORMATION
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.
Other Information
- store at room temperature
- protect from moisture
- Contains FD&C yellow no. 5 (tartrazine) as a color additive
OTC - DO NOT USE SECTION
Do not use
- for teething
- in children under 2 years of age
OTC - STOP USE SECTION
Stop use and ask doctor if
- sore throat is severe or irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
adults and children 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor.
children under 5 years - do not use
INACTIVE INGREDIENT SECTION
Inactive ingredients: Corn starch, FD&C yellow no. 5 (tartrazine), glucose syrup, glycerin, honey, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.
OTC - QUESTIONS SECTION
Questions? Call 1-800-245-2898, Monday - Friday, 9AM to 4PM EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Honey Lemon Sore Throat Lozenges
- Benzocaine
- MENTHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48201-013 | 48201-013-18 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| WATER | 059QF0KO0R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 45c97217-dbb1-1189-e063-6294a90a06b5 | 72dd5790-04bb-65a6-e053-2991aa0a5945 | 2025-12-12 | Warnings | 72dd5790-04bb-65a6-e053-2991aa0a5945 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
