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  5. Label Information: Giltuss Honey Dm Cough

FDA Label for Giltuss Honey Dm Cough

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. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Giltuss Honey Dm Cough 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)

Dextromethorphan HBr, 30 mg


Otc - Purpose



Purposes

Cough Suppresant


Indications & Usage



Uses

  • temporarily relieves:
  • cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep

Warnings



Warnings


Otc - Do Not Use



Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


Otc - Ask Doctor



Ask a doctor before use if you have

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

Otc - Stop Use



Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. 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 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 4 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 6-8 hours
    children 6 to under 12 years of age5 mL every 6-8 hours
    children 4 to under 6 years of age2.5 mL every 6-8 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 natural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, 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®

Honey DM Cough

Made with real honey

ALCOHOL FREE. DYE FREE. NON-DROWSY

RELIEVES

PERSISTENT COUGH UP TO 8 HOURS

HONEY LEMON FLAVOR.

4FL OZ (118 mL)


* Please review the disclaimer below.