Quality Choice Children's Mucus &

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (100 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Potassium Citrate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-10-19

Medication Information

Description

Drug Facts

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50566-9

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Section 50569-3

Ask a doctor before use if the child has

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

Section 50570-1

Do not usein 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.

Section 55105-1

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

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: sodium 3 mg
Tamper -evident: do not use if printed inner seal under cap is torn or missing
store at room temperature
do not refrigerate
dosing cup provided

Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Principal Display Panel 118 Ml Bottle Carton

NDC 63868-771-04

Compare to the Active ingredient in Children’s Mucinex Cough*

Children's

Mucus &Cough Relief

Cough Suppressant

Expectorant

Dextromethorphan HBr

Guaifenesin

Each Dose of Cherry Flavored

Children's

Mucus & Cough Relief:

Controls Cough

Relieves Chest Congestion

Breaks up Mucus

Alcohol-free

See New Dosing information

Cherry

Flavor

4 FL OZ

(118 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

DOSAGE CUP INCLUDED

Distributed by C.D.M.A., Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.®

QC 100% Satisfaction Guaranteed.

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

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

Section 50570-1 (50570-1)

Do not usein 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.

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

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 (Other information)

each 5 mL contains: sodium 3 mg
Tamper -evident: do not use if printed inner seal under cap is torn or missing
store at room temperature
do not refrigerate
dosing cup provided

Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NDC 63868-771-04

Compare to the Active ingredient in Children’s Mucinex Cough*

Children's

Mucus &Cough Relief

Cough Suppressant

Expectorant

Dextromethorphan HBr

Guaifenesin

Each Dose of Cherry Flavored

Children's

Mucus & Cough Relief:

Controls Cough

Relieves Chest Congestion

Breaks up Mucus

Alcohol-free

See New Dosing information

Cherry

Flavor

4 FL OZ

(118 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

DOSAGE CUP INCLUDED

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.®

QC 100% Satisfaction Guaranteed.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.", "50566-9": "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.", "50569-3": "Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma", "50570-1": "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.", "55105-1": "Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant", "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: sodium 3 mg Tamper -evident: do not use if printed inner seal under cap is torn or missing store at room temperature do not refrigerate dosing cup provided", "Inactive ingredients": "Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton": "NDC 63868-771-04 Compare to the Active ingredient in Children’s Mucinex Cough* Children's Mucus &Cough Relief Cough Suppressant Expectorant Dextromethorphan HBr Guaifenesin Each Dose of Cherry Flavored Children's Mucus & Cough Relief: Controls Cough Relieves Chest Congestion Breaks up Mucus Alcohol-free See New Dosing information Cherry Flavor 4 FL OZ (118 mL) IMPORTANT: Keep this carton for future reference on full labeling. DOSAGE CUP INCLUDED Distributed by C.D.M.A., Inc© 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.® QC 100% Satisfaction Guaranteed."}

Quality Choice Children's Mucus &

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information