FDA Label for Despec
View Indications, Usage & Precautions
Despec Product Label
The following document was submitted to the FDA by the labeler of this product International Ethical Labs. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Active ingredients Purpose
(in each 5 mL teaspoonful)
Dextromethorphan
Hydrobromide 10 mg ................ Antitussive
Guaifenesin 100 mg ................ Expectorant
Phenylephrine
Hydrochloride 5 mg .... Nasal Decongestant
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
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.
If pregnant or breast-feeding, ask a health
professional before use.
Ask A Doctor
Ask a doctor before use if you have
a cough that lasts or is chronic such
as occurs with smoking, asthma, chronic
bronchitis, 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
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. A persistent cough
may be a sign of a serious condition.
new symptoms occur
Keep Out Of Reach Of Children
In case of overdose, get medical help or
contact a Poison Control Center right away.
Dosage & Administration
Do not exceed recommended dosage.
Use with enclosed dosage cup.
Adults and Children
12 years of age and
over:
Children 6 to under
12 years of age:
Children under 6
years of age:
2 teaspoonfuls (2 TSP)
every 4 hours, not to
exceed 6 doses in
24 hours.
1 teaspoonful (1 TSP)
every 4 hours, not to
exceed 6 doses in
24 hours.
Consult a doctor.
Other Safety Information
Other information
Store at 59° - 86° F (15° - 30° C)
Inactive Ingredient
citric acid, glycerin, grape flavor,
maltitol, propylene glycol, purified water,
sodium citrate, sodium saccharin, and
sorbitol.
Questions? Comments?
Questions? Comments?
Call 1-787-765-3510.
Manufactured for:
International Ethical Laboratories
San Juan PR 00918-2627
Manufactured by:
Woodfield Pharmaceutical, LLC
Houston, TX 77099
Rev. 09/15
* Please review the disclaimer below.