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Childrens Giltuss Honey Cough & Chest Congestion


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg


OTC - PURPOSE SECTION

Purposes

Cough Suppressant

Expectorant


INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings


OTC - DO NOT USE SECTION

Do not useif your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with asthma

OTC - STOP USE SECTION

Stop use and ask a doctor if the child hasa 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 - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.


DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosinc cup
  • keep dosage cup for use with this product
  • ml = milliliters children under 4 yearsConsult a doctorchildren 4 to under 6 years2.5 mL every 4 hourschildren 6 to under 12 years5 mL every 4 hourschildren 12 years and over10 mL every 4 hours

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredientscarboxymethycellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water, sucralose.


OTC - QUESTIONS SECTION

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.


SPL UNCLASSIFIED SECTION

Tamper Evident: do not use if safety seal is broken or missing.

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children 4-12

Children's Giltuss®

Honey Cough & Chest Congestion

Made with real honey

Alcohol Free, Dye Free, Non Drowsy

COUGH AND COLD

CHEST CONGESTION

LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

HONEY LEMON FLAVOR

4FL OZ (118 mL)