topcare 44-004

topcare 44-004
SPL v4
SPL
SPL Set ID ad199488-a4be-4b6e-b806-67ce8a6e907e
Route
oral
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg


Medication Information

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
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

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

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
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.

Questions Or Comments?

1-800-426-9391

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
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

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
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.

Questions Or Comments? (Questions or comments?)

1-800-426-9391

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


Raw Label Data

All Sections (JSON)