Gilphex Tablet
FDA Label NDC 58552-336

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp. for the product Gilphex (NDC 58552-336). 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 drug facts, purposes, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 390 mg
Phenylephrine HCl 10 mg

Purposes

Expectorant

Nasal Decongestant

Uses

Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies.
Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive,clear stuffy nose,clear nasal passageways, shrinks swollen membranes.

Warnings

Do not use this product more than the recommended dosage, or 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 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 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 tend to recur.

    • These could be signs of  a serious condition.

Directions

Do not exceed recommended doses in a  24 hour period

  • Adults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours.
  • Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours.
  • Children under 6 years of age: ask a doctor.

Other Information

  • store at room temperature, USP.
  •  do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients

Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide, Stearic Acid.

Questions? Call 787-848-9114

Manufactured for:

GIL PHARMACEUTICAL CORP.

Ponce, Puerto Rico 00716

Revised Label: 03/22

Package Label.Principal Display Panel

Gilphex ® Total Release - NDC-58552-336-01 - 100's Bottle Label

Image Description (Gliphex 100s Bottle Label)

Image Description (Gliphex 100s Bottle Label)

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