Active Ingredient
Active ingredients:
(in each 1 mL dropperful)
Dextromethorphan Hydrobromide 5 mg
Guaifenesin 50 mg
Phenylephrine Hydrochloride 2.5 mg
Despec
FDA Label NDC 11584-1110
11 label sections · Submitted to the FDA by International Ethical Labs · 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 active ingredient, purpose, indications & usage, warnings, ask doctor, stop use, keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose:
Antitussive
Expectorant
Nasal Decongestant
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 an MAOI, ask a doctor or pharmacist before giving this product.
Ask Doctor
Ask a doctor before use if the child has:
a cough that lasts or is chronic such as occurs with asthma
a cough that occurs with too much phlegm (mucus)
heart disease
high blood pressure
thyroid disease
diabetes
Stop Use
Stop use and ask a doctor if:
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
nervousness, dizziness, or sleeplessness occur
new symptoms occur
Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
Administer using provided dropper.
AGE
DOSE
Children 2 to under
6 years of age:
1 dropperful (1 mL) every 4 hours,
not to exceed 6 dropperfuls in 24
hours
Children under 2 years of age:
Consult a physician
Inactive Ingredient
Inactive ingredients:
Bitter Mask, Citric Acid, Glycerin, Grape Flavoring, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose.
Other Safety Information
Other information:
Store at 59° - 86°F (15° - 30°C)
Questions
Questions? Comments?
Call 1-787-765-3510
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispensed in a tight, light-resistant container with a child-resistant cap.
Manufactured For:
International Ethical Labs
San Juan, PR 00918-2627
Rev. 04/10/17
* Please review the disclaimer below.
