Brontuss
FDA Label NDC 49963-913

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 Inc. for the product Brontuss (NDC 49963-913). 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, uses, warnings, do not use this product, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients                             Purpose(in each 5 mL teaspoonful)Dextromethorphan Hydrobromide 20 mg...... AntitussiveGuaifenesin 200 mg................................ ExpectorantPhenylephrine Hydrochloride 10 mg..........Decongestant

Uses

temporarily relieves these symptoms, due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do Not Use This Product

  • 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

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
  • new symptoms occur

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.
Adults and Children 12 years of age and older:             
2 teaspoonfuls (10mL) every 6 hours, not to exceed 4 doses in a 24 hour period.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in a 24 hour period.
Children under 6 years of age:
Not recommended for use.

Other Information

Store at 59o-86oF (15o-30oC)

Inactive Ingredients

Cherry flavor, citric acid, maltitol, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

Questions? Comments?

Serious side effects associated with this product may be reported to this number.Call (787)832-6645Operation Hours: Monday - Friday, 8 A.M. to 4 P.M. Atlantic Standard Time (AST)[email protected] for:Portal PharmaceuticalMayaguez, PR 00680Rev. 10/09

Product Packaging:

The packaging below represents the labeling currently used:Principal Display Panel and Side Panel for 118mL Label:NDC 49963-913-04Brontuss DXAntitussive / Expectorant DecongestantEach teaspoonful (5 mL) for oral administration contains:Dextromethorphan HBr.............. 20 mgGuaifenesin.............................200 mgPhenylephrine HCl.................... 10 mgDye Free - Sugar FreeAlcohol Free - Gluten Free4 oz. (118 mL)Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.Supplied in a tight, light-resistant container with a child-resistant cap.Manufactured for:Portal PharmaceuticalMayaguez, PR 00680Rev. 10/09Principal Display Panel and Side Panel for 15 mL Label:NDC 49963-913-15BrontussDXAntitussive / ExpectorantDecongestantEach teaspoonful (5 mL) for oral administration contains:Dextromethorphan HBr.......... 20 mgGuaifenesin........................ 200 mgPhenylephrine HCl................ 10 mgDye Free / Sugar FreeAlcohol Free / Gluten Free15 mL (1/2 fl oz)Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.Supplied in a tight, light-resistant container with a child-resistant cap.Professional Sample:Not For SaleManufactured for:Portal PharmaceuticalMayaguez, PR 00680Rev. 10/09

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