Active Ingredients (In Each Teaspoonful, (5Ml)
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
Broncofin Liquid
FDA Label NDC 53145-026
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Broncofin (NDC 53145-026). 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 active ingredients (in each teaspoonful, (5ml), purpose, uses, do not exceed recommended dosage., do not use, if you are pregnant or breast-feeding, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Nasal decongestant
Uses
Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold or inhaled irritants
Do Not Exceed Recommended Dosage.
If nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor. A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Do Not Use
- this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
- 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
- if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to enlargement of the prostate gland, unless directed by a doctor
If You Are Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over: take 2 teaspoons (10 mL) every 4 hours. Do not exceed 6 doses in 24 hours.
Children under 12 years of age: consult a doctor.
Other Information
Store this product between 15°-30°C (59°-86°F)
Inactive Ingredients
cherry flavor, FD&C red #40, FD&C yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, sucrose, water
Questions?
call 1-800-560-5223 M-F 9 AM to 4 PM Eastern
Package Label.Principal Display Panel
Broncofin (Broncofin)
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