Bronkids
FDA Label NDC 49963-532

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 49963-532). 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 drug facts, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients(in each 5 mL teaspoonful)Chlorpheniramine Maleate 4 mgDextromethorphan Hydrobromide 10 mgPhenylephrine Hydrochloride 10 mg

Purpose

AntihistamineAntitussiveNasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do Not Use This Product

  • if you are taking a prescription monamine 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.

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask A Doctor Or Pharmacist Before Use If You Are

Taking sedatives or tranquilizers.

When Using This Product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • cough or nasal congestion persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition
  • nervousness, dizziness,or sleeplessness occur
  • new symptoms occur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years
of age and over


1 teaspoonful (5 mL)
every 4 to 6 hours, not to
exceed 6 teaspoonfuls
in 24 hours
Children 6 to under 12 years
of age:


1/2 teaspoonful (2.5 mL)
every 4 to 6 hours, not to
exceed 3 teaspoonfuls
in 24 hours
Children under 6 years
of age:
Consult a doctor

Other Information

Store at controlled room temperature 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container with a child-resistant cap.

Inactive Ingredients

Citric Acid, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Strawberry Flavor.

Questions? Comments?

Reports of serious side effects associated with use of the product call 787-832-6645.Rev. 08/11

Product Packaging

The packaging below represents the labeling currently used.Principal display panel and side panel for 118 mL label:NDC 49963-532-04Antihistamine/Antitussive/Nasal DecongestantBronkidsLiquidStrawberry FlavorEach 5 mL (one teaspoonful) fororal administration contains:Chlorpheniramine Maleate.........................4 mgDextromethorphan Hydrobromide.............10 mgPhenylephrine Hydrochloride...................10 mgGluten Free4 fl oz(118 mL)Tamper evident by foil seal under cap.Do not use if foil seal is broken or missing.Manufactured for:PORTALPharmaceuticalMayaguez, PR  00680

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