Qc Quality Choice Children’s

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Citrate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-10-19

Medication Information

Purpose

Expectorant

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

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.

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

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 Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate ,sorbitol, sucralose, xanthan gum.

Active Ingredient (in Each 5 Ml)

Guaifenesin, USP 100 mg

Principal Display Panel 118 Ml Bottle Carton

QC QUALITY CHOICE NDC 63868-770-04

Children's

Mucus relief

Expectorant

Guaifenesin

Oral Solution, USP

Each Dose of Grape Flavored

Children’s Mucus Relief:

Relieves Chest Congestion

Breaks up Mucus

Alcohol Free

See New Dosing Information

Grape

Flavor

4 FL OZ

(118 mL)

IMPORTANT:

Keep this carton for future reference on full labeling.

DOSAGE CUP INCLUDED

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

Distributed by C.D.M.A.,Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

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

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.

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

Purpose

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 Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate ,sorbitol, sucralose, xanthan gum.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Guaifenesin, USP 100 mg

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

QC QUALITY CHOICE NDC 63868-770-04

Children's

Mucus relief

Expectorant

Guaifenesin

Oral Solution, USP

Each Dose of Grape Flavored

Children’s Mucus Relief:

Relieves Chest Congestion

Breaks up Mucus

Alcohol Free

See New Dosing Information

Grape

Flavor

4 FL OZ

(118 mL)

IMPORTANT:

Keep this carton for future reference on full labeling.

DOSAGE CUP INCLUDED

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

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

QC 100% Satisfaction Guaranteed.

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CITRATE", "unii": "EE90ONI6FF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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", "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.", "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", "Purpose": "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 Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate ,sorbitol, sucralose, xanthan gum.", "Active ingredient (in each 5 mL)": "Guaifenesin, USP 100 mg", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton": "QC QUALITY CHOICE NDC 63868-770-04 Children's Mucus relief Expectorant Guaifenesin Oral Solution, USP Each Dose of Grape Flavored Children’s Mucus Relief: Relieves Chest Congestion Breaks up Mucus Alcohol Free See New Dosing Information Grape Flavor 4 FL OZ (118 mL) IMPORTANT: Keep this carton for future reference on full labeling. DOSAGE CUP INCLUDED *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.® Distributed by C.D.M.A.,Inc© 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300 QC 100% Satisfaction Guaranteed."}

Qc Quality Choice Children’s

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information