The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each lozenge)Benzocaine 7.5 mgDextromethorphan Hydrobromide 5 mg
Otc - Purpose
PurposesOral Pain RelieverCough Suppressant
Indications & Usage
- Uses temporarily relieves these symptms:
- Occasional minor mouth irritation, sore mouth and sore throatcough due to minor throat and bronchial irritation as may occur with the common cold
- WarningsMethemoglobinemia 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)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energySore 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
- 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 teethingin children under 2 years of age
Otc - Ask Doctor
- Ask a doctor before use if you have:persistent of chronic cough such as occurs with smoking, asthma, or emphysemacough that occurs with too much phlegm (mucus)
Otc - Stop Use
- Stop use and ask a doctor ifsore mouth symptoms do not improve in 7 daysirritation, pain, or redness persists or worsensswelling developscough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact Poison Control Center right away.
Dosage & Administration
Directionsadults 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 doctorchildren 6 to 12 years of age - 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 doctorchildren under 6 years of age - do not use
Other Safety Information
- Other informationstore at room temperatureprotect from moisture
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
Questions? Or to report an adverse event call
1-800-245-2898, Monday - Friday, 9AM to 4PM EST
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