Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each lozenge) Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 mg
OTC - PURPOSE SECTION
Purposes Oral Pain Reliever Cough Suppressant
Mixed Berry Sore Throat Lozenges
- Manufacturer
- Topco Associates | Bestco Inc.
- Effective date
- 2025-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:37
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Uses temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throat cough due to minor throat and bronichial irritation as may occur with the common cold
Warnings
WARNINGS SECTION
Warnings 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 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 persists or worsens, see your dentist or doctor promptly. 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.
OTC - DO NOT USE SECTION
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. for teething in children under 2 years of age
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Directions And Dosage
OVERDOSAGE SECTION
In case of overdose, get medical help or contact Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions adults and children 12 years and older - Allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor children 6 to 12 years - take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor children under 6 years of age - do not use
Other Label Information
INACTIVE INGREDIENT SECTION
Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.
OTC - QUESTIONS SECTION
Questions? Or to report an adverse event call 1-888-423-0139
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-836-18 | Mixed Berry Sore Throat Lozenges | 18 in 1 BLISTER PACK | LOZENGE | 18 | 7 |
Products#
- Mixed Berry Sore Throat Lozenges
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-836 | 36800-836-18 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each lozenge) Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 mg
OTC - PURPOSE SECTION
Purposes Oral Pain Reliever Cough Suppressant
INDICATIONS & USAGE SECTION
Uses temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throat cough due to minor throat and bronichial irritation as may occur with the common cold
WARNINGS SECTION
Warnings 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 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 persists or worsens, see your dentist or doctor promptly. 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.
OTC - DO NOT USE SECTION
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. for teething in children under 2 years of age
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)
OTC - STOP USE SECTION
Stop use and ask doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
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 12 years and older - Allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor children 6 to 12 years - take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor children under 6 years of age - do not use
OTHER SAFETY INFORMATION
Other information store at room temperature protect from moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.
OTC - QUESTIONS SECTION
Questions? Or to report an adverse event call 1-888-423-0139