Label: BIOPHEX TR- guaifenesin, phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 45737-606-10 - Packager: Advanced Generic Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 30, 2014
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- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
Uses
Temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies
- helps loosen phlegm (mucus)
- loosens nasal congestions
- thin bronchial secretions
- drain bronchial tubes
- make coughs more productive
- clears stuffy nose
- clear nasal passageways
- shrinks swollen membranes
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WARNINGS
Warnings
Do not exceed recommended dosage
Do not use this product if you are taking a 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.
Ask a doctor before use if you have:
- heart disease
- excessive phlegm (mucus)
- high blood pressure
- diabetes
- 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
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: Do not exceed recommended doses in a 24-hour period
Adults and children 12 years of age and over 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours
Children 6 to 12 years of age 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours
Children under 6 years of age Ask a doctor
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOPHEX TR
guaifenesin, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-606 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 388 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code BP;AGC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-606-10 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2014 Labeler - Advanced Generic Corporation (831762971)