Dosage form: tablet, coated
Ingredients: GUAIFENESIN 400mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: EDWARDS PHARMACEUTICALS, INC.
NDC Code: 0485-0250
Disclaimer: 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.
(each tablet contains)
|Guaifenesin 400 mg||Expectorant|
|Phenylephrine HCl 10 mg||Nasal Decongestant|
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis) and helps loosen phlegm (mucus) and thin bronchial secretions to:
- drain bronchial tubes
- make coughs more productive
- nasal stuffiness
- reduces swelling of nasal passages
- helps decongest sinus openings and passages
- 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.
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that is accompanied by excessive phlegm (mucus)
- nervousness, dizziness, or sleeplessness occur
- symptoms are accompanied by a persistent cough for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache
- if symptoms do not improve within 7 days or accompanied by a fever — These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Do 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:||½ tablet every 4 hours, not to exceed 3 tablets in 24 hours|
|Children under 6 years of age:||Consult a doctor.|
- store between 15°-30° C (59°-86° F)
- Caution: do not use if imprinted seal under cap is broken or missing
croscarmellose sodium, hypromellose, lactose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium Iauryl sulfate, stearic acid, titanium dioxide, and triacetin
Edwards Pharmaceuticals, Inc.
Ripley, MS 38663
guaifenesin and phenylephrine hydrochloride tablet, coated
|Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.