Otc - Active Ingredient
ACTIVE INGREDIENTS
(in each 1 mL dropperful)
Dextromethorphan Hydrobromide 5mg
Guaifenesin 50mg
Phenylephrine Hydrochloride 2.5mg
Despec
FDA Label NDC 11584-1110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by International Ethical Labs for the product Despec (NDC 11584-1110). 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 - purpose, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE
Antitussive
Expectorant
Nasal Decongestant
Inactive Ingredient
Inactive ingredients
Bitter Mask, Citric Acid, Glycerin, Grape Flavoring, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose
Dosage & Administration
Directions
Administer using provided dropper.
Children 2 to under 6 years of age: 1 dropperful (1mL) every 4 hours, not to exceed 6 dropperfuls in 24 hours.Children under 2 years of age: Consult a physician
Indications & Usage
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
Warnings
Do not exceed recommended dosage.
Do not use this product in a child who is 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 child’s prescription drug contains MAOI, ask a doctor or pharmacist before giving this product.
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.
* Please review the disclaimer below.
