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  5. Label Information: Giltuss Childrens Cough And Cold

FDA Label for Giltuss Childrens Cough And Cold

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    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 Childrens Cough And Cold 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 ingredients (in each 2.5 mL)

Dextromethorphan HBr 7.5 mg

Guaifenesin 150 mg

Phenylephrine HCI 5 mg


Otc - Purpose



Purposes

Cough Suppressant

Expectorant

Nasal decongestant


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
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes
  • stuffy nose

Otc - Do Not Use



Do not use

  • to sedate a child or make a child sleepy
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Otc - Ask Doctor



Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis

Otc - Stop Use



  • Stop use and ask a doctor if
  • nervousness, dizziness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache

    • These can 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.


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



Children's

GILTUSS®

COUGH & COLD

ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT

Alcohol Free. Sugar Free. Dye Free.

  • COUGH AND COLD
  • CHEST CONGESTION
  • STUFFY NOSE
  • NASAL CONGESTION
  • LOOSEN PHLEGM AND MUCUS
  • SINUS PRESSURE

    • CHERRY FLAVOR

    4 FL OZ (118 mL)


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