Topcare 44-057

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-07

Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 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
- nasal congestion due to a cold
- the intensity of coughing
- stuffy nose
- the impulse to cough to help the child get to sleep

Directions

do not take more than directed
do not take more than 6 doses in any 24-hour period
mL = milliliter
only use the dose cup provided
dose as follows or as directed by a doctor

Age	Dose
children 6 to under 12 years	10 mL every 4 hours
children 4 to under 6 years	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: sodium 3 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-888-423-0139

Principal Display Panel

+TopCare®

health

NDC 76162-057-88

COMPARE TO MUCINEX®

CHILDREN’S MULTI-SYMPTOM COLD

ACTIVE INGREDIENTS*

children's

Multi-Symptom

Cold

Mucus

Relief

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT

GUAIFENESIN - EXPECTORANT

PHENYLEPHRINE HCl - NASAL DECONGESTANT

ORAL SOLUTION

• Controls Cough

• Relieves Chest Congestion

• Breaks Up Mucus

• Relieves

Stuffy Nose

Ages 4

to

11 Years

6.8 FL OZ (201 mL)

BERRY

FLAVOR

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO LNKA0923

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

*This product is not manufactured or distributed by

RB Health (US) LLC, owner of the registered trademark

Mucinex® Children’s Multi-Symptom Cold.

50844 ORG022305788

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TopCare 44-057

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not get better within 7 days or occur with fever
cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 right away.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has

diabetes
heart disease
thyroid disease
high blood pressure
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

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
- nasal congestion due to a cold
- the intensity of coughing
- stuffy nose
- the impulse to cough to help the child get to sleep

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions

do not take more than directed
do not take more than 6 doses in any 24-hour period
mL = milliliter
only use the dose cup provided
dose as follows or as directed by a doctor

Age	Dose
children 6 to under 12 years	10 mL every 4 hours
children 4 to under 6 years	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: sodium 3 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel (Principal display panel)

+TopCare®

health

NDC 76162-057-88

COMPARE TO MUCINEX®

CHILDREN’S MULTI-SYMPTOM COLD

ACTIVE INGREDIENTS*

children's

Multi-Symptom

Cold

Mucus

Relief

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT

GUAIFENESIN - EXPECTORANT

PHENYLEPHRINE HCl - NASAL DECONGESTANT

ORAL SOLUTION

• Controls Cough

• Relieves Chest Congestion

• Breaks Up Mucus

• Relieves

Stuffy Nose

Ages 4

to

11 Years

6.8 FL OZ (201 mL)

BERRY

FLAVOR

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO LNKA0923

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

*This product is not manufactured or distributed by

RB Health (US) LLC, owner of the registered trademark

Mucinex® Children’s Multi-Symptom Cold.

50844 ORG022305788

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TopCare 44-057

When Using This Product (When using this product)

do not exceed recommended dosage.

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

nervousness, dizziness, or sleeplessness occur
symptoms do not get better within 7 days or occur with fever
cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 right away.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

diabetes
heart disease
thyroid disease
high blood pressure
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "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": ""}]

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 nasal congestion due to a cold the intensity of coughing stuffy nose the impulse to cough to help the child get to sleep", "Purpose": "Cough suppressant Expectorant Nasal decongestant", "Directions": "do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor Age Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years 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: sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum", "Questions or comments?": "1-888-423-0139", "Principal display panel": "+TopCare® health NDC 76162-057-88 COMPARE TO MUCINEX® CHILDREN’S MULTI-SYMPTOM COLD ACTIVE INGREDIENTS* children's Multi-Symptom Cold Mucus Relief DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT GUAIFENESIN - EXPECTORANT PHENYLEPHRINE HCl - NASAL DECONGESTANT ORAL SOLUTION • Controls Cough • Relieves Chest Congestion • Breaks Up Mucus • Relieves Stuffy Nose Ages 4 to 11 Years 6.8 FL OZ (201 mL) BERRY FLAVOR TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO LNKA0923 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com *This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Mucinex® Children’s Multi-Symptom Cold. 50844 ORG022305788 PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TopCare 44-057", "When using this product": "do not exceed recommended dosage.", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 right away.", "Active ingredients (in each 5 mL)": "Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg", "Ask a doctor before use if the child has": "diabetes heart disease thyroid disease high blood pressure persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information