BIOPHEX TR- guaifenesin, phenylephrine hcl tablet

Biophex by

Drug Labeling and Warnings

Biophex by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)           Purpose

Guaifenesin .............. 388 mg .................  Expectorant

Phenylephrine HCl ....  10 mg .................   Nasal Decongestant

PURPOSE

Purpose

Expectorant

Nasal Decongestant

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

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

Stop use and ask a doctor if:

• Nervousness, dizziness, or sleeplessness occurs
• symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
• cough and congestion do not improve within 7 days or are accompanied by fever or symptoms tend to recur

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding. Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

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

Inactive ingredients: Colloidal silicon dioxide, crocarmellose sodium, hydroxy propyl methyl cellulose (HPMC), microcrystalline cellulose, polyethylene glycol 400 (PEG-400), povidone, pregelatinized starch, stearic acid, talc

QUESTIONS

Questions or comments? 305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOPHEX  TR
guaifenesin, phenylephrine hcl tablet

Product 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)