Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 mg
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (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 bronchial 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:
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.
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
OTC - DO NOT USE SECTION
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.
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, as 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 of 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 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 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 of age - take 1 lozenge and allow to dissolve slowly in 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 1, FD&C Red 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 1-800-245-2898, Monday through Friday, 9AM to 4PM EST