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  5. Label Information: Giltuss Total Release

FDA Label for Giltuss Total Release

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSES
    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

Giltuss Total Release 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 Ingredients (In Each Tablet)



Guaifenesin 388 mg

Dextromethorphan HBr 28 mg

Phenylephrine HCl 10 mg


Purposes



Expectorant

Antitussive

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



  • Adults and Children over 12 years of age: take 1 tablet every 4 hours as needed. Do not exceed 6 tablets in 24 hours
  • Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed. 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



Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, 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


LBL 4060 Label revised: 04/11


Package/Label Principal Display Panel



GILTUSS®

TOTAL RELEASE
EXPECTORANT, ANTITUSSIVE, AND NASAL DECONGESTANT

SUGAR FREE AND PRESERVATIVE FREE

Each scored tablet contains:

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

Dextromethorphan HBr................28 mg.

Phenylephrine HCl........................10 mg.

100 Tablets

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565


* Please review the disclaimer below.