FDA Label for Mixed Berry Sore Throat And Cough Lozenge
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTHER SAFETY INFORMATION
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Mixed Berry Sore Throat And Cough Lozenge Product Label
The following document was submitted to the FDA by the labeler of this product United Natural Foods, Inc. Dba Unfi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each lozenge)
Benzocaine 7.5 mg
Dextromethorphan hydrobromide 5 mg
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 the common cold
Warnings
Warnings
Sore throat warnings: 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.
Other Safety Information
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, as 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 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
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 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 one 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 take
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? Or to report an adverse event call 1-877-932-7948
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