Bronkids
FDA Label NDC 49963-210

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Portal Pharmaceutical for the product Bronkids (NDC 49963-210). 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 - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients                                                       Purpose(in each teaspoonful (5 mL)ChlorpheniramineMaleate 4 mg ...................................................... AntihistamineDextromethorphanHBr 15 mg ............................................................... AntitussivePhenylephrineHCl 10 mg ................................................. Nasal Decongestant

Otc - Ask Doctor

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI), (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for two 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.

Ask your doctor before use if you have

  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • trouble urinating due to enlarged prostrate gland
  • cough that occurs with to much phlegm (mucus)
  • chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Otc - When Using

When using this product

  • do not exceed recommended dosage
    • may cause excitability especially in children
    • may cause drowsiness: alcohol, sedatives,tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery

Otc - Stop Use

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache.  These may be symptoms 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 the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Purpose

Uses temporarily relieves these symptoms due to cold, hay fever or other upper respiratory allergies
  • runny nose, sneezing, itching of the nose or throat, and itchy watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion

Otc - Questions

Questions? Reports of serious side effects
associated with use of the product call 787-832-6645.

Package Label.Principal Display Panel

Image Of Label (Bronkidslabel)

Image Of Label (Bronkidslabel)

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