Topcare 44-004

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sodium Metabisulfite Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-08-10

Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 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 you get to sleep
- nasal congestion due to a cold

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
adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
children under 12 years: do not use

Do Not Use

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information

each 20 mL contains: sodium 9 mg
use by expiration date on package
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

+TopCare®

health

NDC 76162-040-45

COMPARE TO MUCINEX® FAST-MAX® SEVERE

CONGESTION & COUGH ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief

Severe Congestion

& Cough

DEXTROMETHORPHAN HBr

COUGH SUPPRESSANT

GUAIFENESIN • EXPECTORANT

PHENYLEPHRINE HCl • NASAL DECONGESTANT

MULTI-SYMPTOM RELIEF:

• Controls Cough

• Relieves Nasal &

Chest Congestion

• Thins & Loosens

Mucus

FOR AGES 12+

6 FL OZ (177 mL)

Mixed Berry

Flavored

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO LNKA0924 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here or call 1-888-423-0139 for more information: http://topbrnds.com/49052Q

*This product is not manufactured or distributed by

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

Mucinex® FAST-MAX® Severe Congestion & Cough.

50844 REV0724A00445

Topcare 44-004

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 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have

difficulty in urination due to enlargement of the prostate gland
thyroid disease
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
high blood pressure
heart disease
diabetes
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
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold

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
adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
children under 12 years: do not use

Do Not Use (Do not use)

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information (Other information)

each 20 mL contains: sodium 9 mg
use by expiration date on package
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

+TopCare®

health

NDC 76162-040-45

COMPARE TO MUCINEX® FAST-MAX® SEVERE

CONGESTION & COUGH ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief

Severe Congestion

& Cough

DEXTROMETHORPHAN HBr

COUGH SUPPRESSANT

GUAIFENESIN • EXPECTORANT

PHENYLEPHRINE HCl • NASAL DECONGESTANT

MULTI-SYMPTOM RELIEF:

• Controls Cough

• Relieves Nasal &

Chest Congestion

• Thins & Loosens

Mucus

FOR AGES 12+

6 FL OZ (177 mL)

Mixed Berry

Flavored

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO LNKA0924 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here or call 1-888-423-0139 for more information: http://topbrnds.com/49052Q

*This product is not manufactured or distributed by

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

Mucinex® FAST-MAX® Severe Congestion & Cough.

50844 REV0724A00445

Topcare 44-004

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 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

difficulty in urination due to enlargement of the prostate gland
thyroid disease
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
high blood pressure
heart disease
diabetes
cough that occurs with too much phlegm (mucus

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "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": "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": "SODIUM METABISULFITE", "unii": "4VON5FNS3C", "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 the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold", "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 adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use", "Do not use": "if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "Other information": "each 20 mL contains: sodium 9 mg use by expiration date on package store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)", "Inactive ingredients": "anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "+TopCare® health NDC 76162-040-45 COMPARE TO MUCINEX® FAST-MAX® SEVERE CONGESTION & COUGH ACTIVE INGREDIENTS* MAXIMUM STRENGTH Mucus Relief Severe Congestion & Cough DEXTROMETHORPHAN HBr COUGH SUPPRESSANT GUAIFENESIN • EXPECTORANT PHENYLEPHRINE HCl • NASAL DECONGESTANT MULTI-SYMPTOM RELIEF: • Controls Cough • Relieves Nasal & Chest Congestion • Thins & Loosens Mucus FOR AGES 12+ 6 FL OZ (177 mL) Mixed Berry Flavored TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO LNKA0924 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Visit here or call 1-888-423-0139 for more information: http://topbrnds.com/49052Q *This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Mucinex® FAST-MAX® Severe Congestion & Cough. 50844 REV0724A00445 Topcare 44-004", "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 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.", "If pregnant or breast-feeding,": "ask a health professional before use.", "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 20 mL)": "Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "difficulty in urination due to enlargement of the prostate gland thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure heart disease diabetes 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