Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID aa1eb90c-e565-455f-8978-6f2f9e00a814
Route
ORAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Propyl Gallate Sodium Benzoate Sodium Citrate Sorbitol Fd&c Red No. 40 Glycerin Propylene Glycol Water Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-30

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of botherosme 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
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 products
  • mL = milliliter
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and older: 20 mL every 4 hours
  • children under 12 years of age: 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.

Package Label
TOPCARE HEALTH Mucus Relief DM Maximum Strength
Other Information
  • each 20 mL contains: sodium 20 mg 
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients

anhydrous citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

 call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX® DM MAX ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief DM Max

DEXTROMETHORPHAN HBr 20 mg COUGH SUPPRESSANT

GUAIFENESIN 400 mg EXPECTORANT

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus
  • 4-Hour Dosing

FOR AGES 12 +

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max.

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

www.topcarebrand.com

When Using This Product,

do not use more than directed

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.

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 (1800-222-1222) right away.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • 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 botherosme 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
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 products
  • mL = milliliter
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and older: 20 mL every 4 hours
  • children under 12 years of age: 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.

Package Label
TOPCARE HEALTH Mucus Relief DM Maximum Strength
Other Information (Other information)
  • each 20 mL contains: sodium 20 mg 
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

 call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX® DM MAX ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief DM Max

DEXTROMETHORPHAN HBr 20 mg COUGH SUPPRESSANT

GUAIFENESIN 400 mg EXPECTORANT

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus
  • 4-Hour Dosing

FOR AGES 12 +

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max.

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

www.topcarebrand.com

When Using This Product, (When using this product,)

do not use more than directed

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.

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 (1800-222-1222) right away.

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

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)