Biophex
FDA Label NDC 45737-606

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Generic Corporation for the product Biophex (NDC 45737-606). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients (in each tablet)           Purpose

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

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

Otc - 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

Otc - 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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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

Otc - Questions

Questions or comments? 305-403-3788

Package Label.Principal Display Panel

Biophex Label (Biophextr)

Biophex Label (Biophextr)

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