Dosage form: tablet, multilayer
Ingredients: GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Capellon Pharmaceuticals, LLC
NDC Code: 64543-340
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.
Guaifenesin, USP 200 mg
Phenylephrine HCl, USP 5 mg
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- temporarily restores freer breathing through the nose
- promotes sinus drainage
- temporarily relieves sinus congestion and pressure
Do not use 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
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by excessive phlegm (mucus)
do not exceed the recommended dosage
- 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. These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
- take with a full glass of water
- this product can be administered without regard for timing of meals
- adults and children 12 years of age and older: two tablets every 4 hours
- children 6 to 12 years of age: one tablet every 4 hours
- store at 20°- 25°C (68°- 77°F)
- tamper evident: do not use if foil seal under the cap is broken or missing.
- contains less than 1 mg sodium in each tablet
- contains 6 mg calcium in each tablet
calcium phosphate, colloidal silicon dioxide, crospovidone polyplasdone, FD&C blue #1, magnesium stearate (veg.), microcrystalline cellulose, povidone and silicified microcrystalline cellulose.
Serious side effects may be reported to this number, call (817) 595-5820 (8 am to 5 pm CST).
guaifenesin and phenylephrine hydrochloride tablet, multilayer
|Labeler - Capellon Pharmaceuticals, LLC (124568093)|
|Sovereign Pharmaceuticals, LLC||623168267||MANUFACTURE(64543-340)|
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.