Childrens Giltuss Honey Dm Cough Solution
FDA Label NDC 58552-144

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp for the product Childrens Giltuss Honey Dm Cough (NDC 58552-144). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each 5 mL)

Dextromethorphan HBr, 15 mg

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 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if the child has

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

Otc - Stop Use

Stop use and ask a doctor if the child has a cough that 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

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
    • children under 4 yearsConsult a doctor
    children 4 to under 6 years2.5 mL every 6-8 hours
    children 6 to under 12 years5 mL every 6-8 hours
    children 12 years and over10 mL every 6-8 hours

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

Children 4-12

Children's Giltuss®

Honey DM Cough

Alcohol Free. Dye Free. Non Drowsy.

PERSISTENT COUGH UP TO 8 HOURS

Made with real honey

HONEY LEMON FLAVOR.

4FL OZ (118 mL)

* Please review the disclaimer below.