Childrens Mucus And Cough Relief Liquid
FDA Label NDC 70000-0630

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 Childrens Mucus And Cough Relief (NDC 70000-0630). 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, warning, do not use, ask a doctor before use if the child has, stop use and ask a doctor if, 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

→ Active Ingredients (in Each 5 Ml)

→ Purpose

→ Uses

→ Warning

→ Do Not Use

→ Ask A Doctor Before Use If The Child Has

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Comments?

→ Principal Display Panel

Active Ingredients (In Each 5 Ml)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

Purpose

Cough suppressant
Expectorant

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 impulse to cough to help your child get to sleep
- the intensity of coughing

Warning

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

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

Stop Use And Ask A Doctor If

cough lasts more than 7 days, comes back, or is accompanied by 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
mL=milliliter

Age	Dose
children 6 years to under 12 years	5 mL-10 mL every 4 hours
children 4 years to under 6 years	2.5 mL - 5 mL every 4 hours
children under 4 years	do not use

Other Information

each 5 mL contains: potassium 5 mg, sodium 5 mg
store between 20 to 25°C (68 to 77°F)
do not refrigerate
dosing cup provided

Inactive Ingredients

citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum