Otc - Active Ingredient
Active Ingredients (in each lozenge)
Benzocaine 7.5mg
Dextromethorphan Hydrobromide 5mg
Mixed Berry Sore Throat And Cough Lozenges Lozenge
FDA Label NDC 37808-062
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heb for the product Mixed Berry Sore Throat And Cough Lozenges (NDC 37808-062). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Oral Pain Reliever
Cough Suppressant
Indications & Usage
Uses temporarily relieves these symptoms:
occasiomal minor mouth irritation, sore mouth and sore throat
cough due to minor throat and bronchial ititation as may occue with the common cold
Warnings
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash nausea or vomiting consult a 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 is 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 stoping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have:
persistant or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)
Otc - Stop Use
Stop use and ask a 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 persistant 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.
Dosage & Administration
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 logenges in 24 hours, or as directed by a doctor
children 6 to 12 years of age: take 1 lozenge and allow it 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
Storage And Handling
store at room temperature
protect from moisture
Inactive Ingredient
Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, glycerin, FD&C blue 1, FD&C red 40, natural and artificial flavors, medium chain triglycerires, propylene glycol, soybean oil, sucrose, and water.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898, Monday through Friday, 9AM - 4PM EST
* Please review the disclaimer below.
