Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 98dd0ba6-0109-46b2-92df-11a030984240
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) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-28

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Cough suppressant Expectorant Nasal Decongestant


Medication Information

Purpose

Cough suppressant Expectorant Nasal Decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

do not use more than directed.

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
Purposes

Cough suppressant

Expectorant

Nasal Decongestant

Directions
  • do not take more than 6 doses in a 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with products
  • shake well before using
  • mL=milliliter
  • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use


Do Not Use
  • for children under 12 years of age
  • 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 Maximum Strength Mucus Relief Severe Congestion & Cough
Other Information
  • each 20 mL contains: sodium 17 mg
  • store between 20-25ºC (68º-77ºF). Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Questions Or Comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX® SEVERE CONGESTION & COUGH ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief

Severe Congestion and Cough

DEXTROMETHORPHAN HBr 20 mg COUGH SUPPRESSANT

GUAIFENESIN 400 mg • EXPECTORANT

PHENYLEPHRINE HCI 10 mg •  NASAL DECONGESTANT

MULTI-SYMPTOM RELIEF:

  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thins & Loosens Mucus

FOR AGES 12 +

FL OZ (mL)

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

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

DISTRIBUTED BY TOPCO ASSOCIATED LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with a fever
  • cough 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 (1-800-222-1222) 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
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland 
  • 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

do not use more than directed.

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
Purposes

Cough suppressant

Expectorant

Nasal Decongestant

Directions
  • do not take more than 6 doses in a 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with products
  • shake well before using
  • mL=milliliter
  • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use


Do Not Use (Do not use)
  • for children under 12 years of age
  • 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 Maximum Strength Mucus Relief Severe Congestion & Cough
Other Information (Other information)
  • each 20 mL contains: sodium 17 mg
  • store between 20-25ºC (68º-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, 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® SEVERE CONGESTION & COUGH ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief

Severe Congestion and Cough

DEXTROMETHORPHAN HBr 20 mg COUGH SUPPRESSANT

GUAIFENESIN 400 mg • EXPECTORANT

PHENYLEPHRINE HCI 10 mg •  NASAL DECONGESTANT

MULTI-SYMPTOM RELIEF:

  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thins & Loosens Mucus

FOR AGES 12 +

FL OZ (mL)

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

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

DISTRIBUTED BY TOPCO ASSOCIATED LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

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 a fever
  • cough 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 (1-800-222-1222) 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)
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland 
  • 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

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