(guaifenesin, phenylephrine hydrochloride)
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug FactsActive ingredients
(in each tablet)
Guaifenesin 380 mg
Phenylephrine HCl 10 mg
UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- nasal congestion
- reduces swelling of nasal passage
WarningsDo 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, chronic bronchitis, or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- 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. A persistent cough may be a sign of a serious condition.
- new symptoms occur
DirectionsDo not exceed recommended dosage.
|Adults and children|
12 years of age and over:
|1 tablet every 4 hours, not to
exceed 6 tablets in 24 hours.
|Children 6 to under 12|
years of age:
|1/2 tablet every 4 hours, not to
exceed 3 tablets in 24 hours.
6 years of age:
|Consult a physician.
Other informationStore at controlled room temperature between 15°- 30°C (59°- 86°F).
Supplied in a tight, light-resistant container with a child-resistant cap.
Contains color additives including FD&C Yellow No. 5 (tartrazine).
Deconex IR Tablets are green, oval-shaped, scored tablets, debossed "POLY" bisect "716" on one side, and plain on the other side.
Inactive ingredientscolloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid.
Questions? Comments?Call 1-800-882-1041
Quitman, MS 39355
1 (800) 882-1041
Product PackagingThe packaging below represents the labeling currently used.
Principal display panel and side panel for 60 tablets label:
EXPECTORANT · NASAL DECONGESTANT
Each tablet contains:
Phenylephrine HCl......................10 mg
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Quitman, MS 39355
guaifenesin, phenylephrine hydrochloride tablet
|Labeler - Poly Pharmaceuticals (198449894)|
|Registrant - Pernix Manufacturing, LLC (078641814)|
|Pernix Manufacturing, LLC dba Great Southern Laboratories||078641814||manufacture(50991-716)|
Document Id: 27c3d7bb-1df8-43cb-8344-fcafe4b734cb
Set id: 52e4dd62-0a34-4072-aee4-1afa3d04329d
Effective Time: 20121026