Leader Childrens Multi Symptom Cold Liquid
FDA Label NDC 70000-0629

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Childrens Multi Symptom Cold (NDC 70000-0629). 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 active ingredients (in each 5 ml), purpose, uses, warnings, do not use, ask a doctor before use if the child has, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep 
    • nasal congestion due to a cold
    • stuffy nose

Warnings

.

Do Not Use

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.

Ask A Doctor Before Use If The Child Has

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

When Using This Product

  • do not use more than directed

Stop Use And Ask Doctor If

  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever 
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache.

    •        These could be signs of a serious illness.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
    • Age Dose 
    children 6 years to under 12 years10 mL every 4 hours
    children 4 years to under 6 years5 mL every 4 hours
    children under 4 yearsdo not use
    • mL=milliliter

Other Information

  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30 °C (59-86 °F)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients

citric acid anhydrous, D&C red #33, dextrose, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est

Principal Display Panel

LEADER

NDC 70000-0629-1

Children's Multi-Symptom Cold

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl


Cough Suppressant

Expectorant

Nasal Decongestant


Very Berry Flavor


Ages 4+ Years

Relieves:

Stuffy Nose

Chest Congestion

Controls Cough

Breaks Up Mucus

COMPARE TO

CHILDREN'S MUCINEX®

MULTI-SYMPTOM COLD

active ingredients*


4FL OZ (118 mL)

Ldr_615_carton (Leader615carton)

Ldr_615_carton (Leader615carton)

615_ldr_labl (615 Ldr)

615_ldr_labl (615 Ldr)

* Please review the disclaimer below.