Dosage form: tablet
Ingredients: Guaifenesin 400mg, Phenylephrine Hydrochloride 10mg, Dextromethorphan Hydrobromide 20mg
Labeler: MCR American Pharmaceuticals, Inc.
NDC Code: 58605-423
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.
(in each immediate-release tablet)
|Dextromethorphan HBr 20 mg||Antitussive|
|Guaifenesin 400 mg||Expectorant|
|Phenylephrine HCl 10 mg||Nasal Decongestant|
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
- cough due to minor throat or bronchial irritation associated with a cold
- cough impulses without narcotics
- helps loosen phlegm and thin bronchial secretions to make coughs more productive
- nasal congestion
- runny nose
- itching of the nose or throat
- itchy, watery eyes
- Do not exceed recommended dosage.
- a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor
- 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
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor before use if you are taking sedatives or tranquilizers
- nervousness, dizziness or sleeplessness occur
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Do not exceed recommended dosage.
|Adults and children 12 years of age and over:||1 tablet by mouth every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor|
|Children 6 to under 12 years of age:||1/2 tablet by mouth every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor|
Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate
Antitussive • Expectorant • Nasal Decongestant
|Each immediate-release tablet contains:|
|Dextromethorphan HBr||20 mg|
|Phenylephrine HCl||10 mg|
This bottle is not be dispensed to consumer.
Dispense in a tight light-resistant container with
a child-resistant cap.
Store at 59°-86°F (15°-30°C) [see USP
Controlled Room Temperature]
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet
|Labeler - MCR American Pharmaceuticals, Inc. (783383011)|
|MCR American Pharmaceuticals, Inc.||783383011||MANUFACTURE|
|TG United Inc||172837085||MANUFACTURE|
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.