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  5. Label Information: Giltuss Sinus And Chest Congestion

FDA Label for Giltuss Sinus And Chest Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Giltuss Sinus And Chest Congestion 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.

Otc - Active Ingredient



Active Ingredient (in each tablet)

Guaifenesin 388 mg

Phenylephrine HCl 10 mg


Otc - Purpose



Purpose

Expectorant

Nasal Decongestant


Indications & Usage



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
  • clears stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes

Warnings



Warnings


Otc - Do Not Use



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.

Otc - Ask Doctor



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 tend to recur.

    • These could be signs of a serious condition.


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 accidental 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 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

Inactive Ingredient



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.


Otc - Questions



Questions? Call 787-848-9114


Package Label.Principal Display Panel



MAXIMUM STRENGTH

GILTUSS®

SINUS & CHEST CONGESTION

20 TABLETS

NON-DROWSY. DYE FREE. PRESERVATIVE . SODIUM FREE

RELIEVES

  • STUFFY NOSE
  • NASAL CONGESTION
  • SINUS PRESSURE
  • CHEST CONGESTION
  • LOOSENS PHLEGM AND MUCUS


* Please review the disclaimer below.