Leader Childrens Mucus And Cough

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (100 mg)

Inactive Ingredients

Anhydrous Citric Acid Dextrose, Unspecified Form D&c Red No. 33 Fd&c Red No. 40 Glycerin Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Saccharin Sodium Sorbitol Sodium Hydroxide Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-22

Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg

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

.

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

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.

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

Questions Comments?

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

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

Principal Display Panel

LEADER

NDC 70000-0630-1

Children's Mucus & Cough Relief

Dextromethorphan HBr, 5mg

Guaifenesin 100 mg

cough Suppressant

Expectorant

Cherry Flavor

Ages 4+ Years

Controls Cough

Relieves Chest Congestion

Thins and Loosen Mucus

COMPARE TO CHILDREN'S MUCINEX^® COUGH

active ingredients*

4 FL OZ (118mL)

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.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

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)

Structured Label Content

Uses (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

Purpose (PURPOSE)

Cough suppressant

Expectorant

Warning (WARNING)

.

Directions (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

Do Not Use (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.

Other Information (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

Questions Comments? (QUESTIONS COMMENTS?)

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

Inactive Ingredients (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

LEADER

NDC 70000-0630-1

Children's Mucus & Cough Relief

Dextromethorphan HBr, 5mg

Guaifenesin 100 mg

cough Suppressant

Expectorant

Cherry Flavor

Ages 4+ Years

Controls Cough

Relieves Chest Congestion

Thins and Loosen Mucus

COMPARE TO CHILDREN'S MUCINEX^® COUGH

active ingredients*

4 FL OZ (118mL)

Stop Use and Ask A Doctor If (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 (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.

Active Ingredients (in Each 5 Ml) (ACTIVE INGREDIENTS (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Ask A Doctor Before Use If the Child Has (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)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "PURPOSE": "Cough suppressant Expectorant", "WARNING": ".", "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", "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.", "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", "QUESTIONS COMMENTS?": "call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est", "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", "PRINCIPAL DISPLAY PANEL": "LEADER NDC 70000-0630-1 Children's Mucus & Cough Relief Dextromethorphan HBr, 5mg Guaifenesin 100 mg cough Suppressant Expectorant Cherry Flavor Ages 4+ Years Controls Cough Relieves Chest Congestion Thins and Loosen Mucus COMPARE TO CHILDREN'S MUCINEX ® COUGH active ingredients* 4 FL OZ (118mL)", "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.", "ACTIVE INGREDIENTS (in each 5 mL)": "Dextromethorphan HBr 5 mg Guaifenesin 100 mg", "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)"}

Leader Childrens Mucus And Cough

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information