Mucinex® Fast-max ®

Mucinex® Fast-max ®
SPL v12
SPL
SPL Set ID 3270f369-7a40-186d-e063-6394a90a8526
Route
ORAL
Published
Effective Date 2022-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Methacrylic Acid And Ethyl Acrylate Copolymer Croscarmellose Sodium Fd&c Blue No. 2 Aluminum Fd&c Red No. 40 Mica Microcrystalline Cellulose Polyethylene Glycol 3350 Polysorbate 80 Polyvinyl Alcohol, Unspecified Povidone K30 Sodium Bicarbonate Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: VVV;SCC Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product do not use more than directed

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
Active ingredients (in each caplet) Purposes
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Section 55106-9

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Directions
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets 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.
Questions?

1-866-MUCINEX (1-866-682-4639)You may also report side effects to this phone number.

Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

aluminum, croscarmellose sodium, FD&C blue no. 2

aluminum lake, FD&C red no. 40 aluminum lake,

methacrylic acid and ethyl acrylate copolymer,

mica, microcrystalline cellulose, polyethylene glycol,

polysorbate 80, polyvinyl alcohol, povidone, sodium

bicarbonate, talc, titanium dioxide

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 comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • 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)
Principal Display Panel 20 Caplet Blister Pack Carton

NDC 63824-157-20


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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purposes
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Section 55106-9 (55106-9)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Directions
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets 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.
Questions?

1-866-MUCINEX (1-866-682-4639)You may also report side effects to this phone number.

Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

aluminum, croscarmellose sodium, FD&C blue no. 2

aluminum lake, FD&C red no. 40 aluminum lake,

methacrylic acid and ethyl acrylate copolymer,

mica, microcrystalline cellulose, polyethylene glycol,

polysorbate 80, polyvinyl alcohol, povidone, sodium

bicarbonate, talc, titanium dioxide

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 comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • 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)
Principal Display Panel 20 Caplet Blister Pack Carton (Principal Display Panel - 20 Caplet Blister Pack Carton)

NDC 63824-157-20


Advanced Ingredient Data


Raw Label Data

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