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  5. Label Information: Gilphex

FDA Label for Gilphex

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS? CALL 787-848-9114
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gilphex Product Label

The following document was submitted to the FDA by the labeler of this product Gil Pharmaceutical Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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