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Dosage form: tablet
Ingredients: GUAIFENESIN 380mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: BUREL PHARMACEUTICALS, INC
NDC Code: 35573-323
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 380 mg||Expectorant|
|Phenylephrine HCl 10 mg||Nasal Decongestant|
Uses Temporarily 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 passages
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 know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a cough that occurs with with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistant headache. A persistant cough may be a sign of a serious condition
- New symptoms occur
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 right away.
|Adult 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.|
|Children inder 6 years of age:||Consult a physician.
Relcof IR Tablets are white, oval-shaped, scored tablets, debossed "BL" bisect "323" on one side, and plain on the other side.
Inactive Ingredients: colloidal silicon dioxide, croscrmellose sodium, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid.
Other Information: Store at controlled room temperature between 15° - 30°C (59°-86°F).
To report a serious adverse event or obtain product information, contact 1-601-706-9819
Manufactured For: Burel Pharmaceuticals, Inc. • 199 Interstate Dr. • Richland, MS 39218
Each tablet contains:
Phenylephrine HCl...............................10 mg
Tamper evident by foil seal uder cap.
Do not use if foil seal is broken or missing.
Net Content: 60 Tablets
guaifenesin, phenylephrine hcl tablet
|Labeler - BUREL PHARMACEUTICALS, INC (002152814)|