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  5. Label Information: Giltuss Ex Expectorant

FDA Label for Giltuss Ex Expectorant

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Giltuss Ex Expectorant 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 10 mL)

Guaifenesin, 400 mg


Otc - Purpose



Purpose

Expectorant


Indications & Usage



Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings



Warnings


Otc - Ask Doctor



Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use



Stop use and ask a doctor if cough lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup
  • keep dosage cup for use with this product
  • ml = milliliters
    adults and children 12 years and over10 mL every 4 hours
    children 6 to under 12 years of age5 mL every 4 hours
    children 4 to under 6 years of age2.5 mL every 4 hours
    children under 4 years of ageConsult a doctor

Storage And Handling



Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive Ingredient



Inactive ingredients citric acid, glycerin, methylparaben. natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.


Otc - Questions



Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.


Package Label.Principal Display Panel



MAXIMUM STRENGTH

Giltuss® EX EXPECTORANT

ALCOHOL FREE. SUGAR FREE. DYE FREE. NON-DROWSY

RELIEVES

CHEST CONGESTION

LOOSENS AND LIQUIFIES PHLEGM

LIQUIFIES AND REMOVE MUCUS

HELPS TO EXPEL PHLEGM IN CHEST AND THROAT

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)


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