Otc - Active Ingredient
Active ingredients (in each lezenge)
Benzocaine 7.5 mg
Dextromethorphan hydrobromide 5 mg
Mixed Berry Sore Throat And Cough Lozenge
FDA Label NDC 55910-066
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dollar General Corporation for the product Mixed Berry Sore Throat And Cough Lozenge (NDC 55910-066). 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, drug interactions, 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:
occasional minor mouth irritation, sore mouth and sore throat
cough due to minor throat and bronchial irritation as may occur with a 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 contact a doctor promptly.
Allergy alert: Do not use if you have a history of allergy to local anesthetics such as prociane, butacaine, benzocaine, or other "caine" anesthetics.
Drug Interactions
Do not use if you are now takin a prescription monoamineoxidase 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.
Otc - Ask Doctor
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
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 persistent headache. These could be signs of a serious condition.
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.
Overdosage
In case of overdose, get medical help or contact Poison Control Center right away.
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 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
Inactive Ingredient
Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, glycerin, FD&C blue no. 1, FD&C red no. 40, natural and artificial flavors, medium chain triglycerides, propylene glycol, soybean oil, sucrose, and water.
Otc - Questions
Questions? Call 888-309-9030
* Please review the disclaimer below.
