Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (100 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2022-04-18 Until 2027-04-18

Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg

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

Purposes

Cough suppressant

Expectorant

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL = milliliter
shake well before using

age	dose
children 6 to under 12 years	5-10 mL every 4 hours
children 4 to 5 years	2.5-5 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 taking this product.

Package Label

Topcare Children's Mucus Relief Cough Cherry Liquid

Other Information

each 5 mL contains: sodium 2 mg
store between 20-25ºC (68-77º). Do not refrigerate.

Inactive Ingredients

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

Questions Or Comments?

Call toll free 1-888-423-0139

Principal Display Panel

Compare to Children's Mucinex® Cough active ingredients*

Children's Cough Mucus Relief

Dextromethorphan HBr 5 mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

Relieves:

cough
chest congestion
breaks up mucus

Alcohol Free

For Ages 4 to 11 Years

Cherry Flavor

FL OZ (mL)

Dosing Cup Included

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected] www.topcarebrand.com

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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

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

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

Purposes

Cough suppressant

Expectorant

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL = milliliter
shake well before using

age	dose
children 6 to under 12 years	5-10 mL every 4 hours
children 4 to 5 years	2.5-5 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 taking this product.

Package Label

Topcare Children's Mucus Relief Cough Cherry Liquid

Other Information (Other information)

each 5 mL contains: sodium 2 mg
store between 20-25ºC (68-77º). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-423-0139

Principal Display Panel

Compare to Children's Mucinex® Cough active ingredients*

Children's Cough Mucus Relief

Dextromethorphan HBr 5 mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

Relieves:

cough
chest congestion
breaks up mucus

Alcohol Free

For Ages 4 to 11 Years

Cherry Flavor

FL OZ (mL)

Dosing Cup Included

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected] www.topcarebrand.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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)

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

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", "Purposes": "Cough suppressant Expectorant", "Directions": "do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter shake well before using age dose children 6 to under 12 years 5-10 mL every 4 hours children 4 to 5 years 2.5-5 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 taking this product.", "Package Label": "Topcare Children's Mucus Relief Cough Cherry Liquid", "Other information": "each 5 mL contains : sodium 2 mg store between 20-25ºC (68-77º). Do not refrigerate.", "Inactive ingredients": "citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum", "Questions or comments?": "Call toll free 1-888-423-0139", "Principal Display Panel": "Compare to Children's Mucinex® Cough active ingredients* Children's Cough Mucus Relief Dextromethorphan HBr 5 mg - Cough Suppressant Guaifenesin 100 mg - Expectorant Relieves: cough chest congestion breaks up mucus Alcohol Free For Ages 4 to 11 Years Cherry Flavor FL OZ (mL) Dosing Cup Included *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cough. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. Distributed by TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 topcare@topco.com www.topcarebrand.com", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.", "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": "cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information