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  5. Label Information: Gilphex Tr

FDA Label for Gilphex Tr

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF THE REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Gilphex Tr 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.

Active Ingredient (In Each Tablet)



Guaifenesin 388 mg

Phenylephrine HCl 10 mg


Purpose



Expectorant

Nasal Decongestant


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 congestion
  • thin bronchial secretions
  • drain bronchial tubes
  • make coughs more productive
  • clears stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes

Do Not Use



  • more than the recommended dosage
  • this product 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.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of The Reach Of Children.



In case of accidental overdose, get medical help or contact a Poison Control Center immediately.


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 blister seal is broken

Inactive Ingredients



Croscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.


Questions?



Call 787-848-9114


Manufactured for:

GIL PHARMACEUTICAL CORP.,

Ponce, Puerto Rico 00717-1565


Rev. 05/11


Package/Label Principal Display Panel



NDC: 58552-313-01

GILPHEX TOTAL RELEASE

EXPECTORANT AND NASAL DECONGESTANT

DYE FREE AND PRESERVATIVE FREE

Each scored tablet contains:

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

100 Tablets

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565


* Please review the disclaimer below.