The following Structured Product Label (SPL) was submitted to the FDA by International Ethical Laboratories, Inc for the product Despec (NDC 11584-1046). 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 warnings and precautions, inactive ingredient, otc - purpose, otc - active ingredient, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Warnings
Do not exceed recommended dosage.
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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.
Inactive Ingredients citric acid, glycerin, grape flavor, maltitol, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.
Uses
Temporarily relieves these symptoms due to the common cold, high 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
Active Ingredient Purpose
(in each 5mL teaspoonful)
Dextromethorphan Hydrobromide 15mg…. Antitussive
Guaifenesin 100mg ………………………… Expectorant
Phenylephrine Hydrochloride 5mg ……….. Decongestant
Keep out of the reach of children. In case of accidental over dose seek professional help or contact a Poison Control Center immediately.
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.
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.
Uses
Temporarily relieves these symptoms due to the common cold, high 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 congestionreduces swelling of nasal
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