Maximum Strength Mucus Relief 

Maximum Strength Mucus Relief 
SPL v1
SPL
SPL Set ID 6c4e867b-24b9-4525-9fab-10f1e7910b13
Route
ORAL
Published
Effective Date 2025-02-13
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Acetaminophen (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-13

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg 

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg 

Use(s)

temporarily relieves these common cold and flu symptoms:

  • sore throat
  • nasal congestion
  • minor aches and pains
  • headache
  • cough due to minor throat and bronchial irritation
  • sinus congestion and pressure
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum

    daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: acetaminophen may cause severe skin

reactions. Symptoms may include: 

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours.
  • Children under 12 years of age: Do not use.
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.


Other Information

each 20 ml contains: sodium 15 mg

• store between 15-30ºC (59-86ºF)

• do not refrigerate

• dosing cup provided

Inactive Ingredients

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Principal Display Panel

NDC 83324-143-06

QC® QUALITY CHOICE

 

*Compare to the Active Ingredients in Maximum Strength Mucinex® Fax Max™ Cold, Flu & Sore Throat

 

Maximum Strength Mucus Relief 

Cold, Flu & Sore Throat



Acetaminophen

Pain Reliever & Fever Reducer

Dextromethorphan HBr  

 Cough Suppressant

Guaifenesin  

 Expectorant

Phenylephrine HCI 

 Nasal Decongestant

 

For Ages 12+



6 FL OZ (177 mL)



 

When Using This Product

• do not use more than directed

Stop Use and Ask Doctor If
  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash, fever 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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCI 10 mg 

Ask A Doctor Before Use If You Have

• liver disease

• 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)

Ask A Doctor Or Pharmacist Before Use If

you are taking the blood thinning drug warfarin


Structured Label Content

Use(s) (USE(S))

temporarily relieves these common cold and flu symptoms:

  • sore throat
  • nasal congestion
  • minor aches and pains
  • headache
  • cough due to minor throat and bronchial irritation
  • sinus congestion and pressure
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Purpose (PURPOSE)

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Warnings (WARNINGS)

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum

    daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: acetaminophen may cause severe skin

reactions. Symptoms may include: 

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Directions (DIRECTIONS)
  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Adults and children 12 years 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)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.


Other Information (OTHER INFORMATION)

each 20 ml contains: sodium 15 mg

• store between 15-30ºC (59-86ºF)

• do not refrigerate

• dosing cup provided

Inactive Ingredients (INACTIVE INGREDIENTS)

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-143-06

QC® QUALITY CHOICE

 

*Compare to the Active Ingredients in Maximum Strength Mucinex® Fax Max™ Cold, Flu & Sore Throat

 

Maximum Strength Mucus Relief 

Cold, Flu & Sore Throat



Acetaminophen

Pain Reliever & Fever Reducer

Dextromethorphan HBr  

 Cough Suppressant

Guaifenesin  

 Expectorant

Phenylephrine HCI 

 Nasal Decongestant

 

For Ages 12+



6 FL OZ (177 mL)



 

When Using This Product (WHEN USING THIS PRODUCT)

• do not use more than directed

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash, fever 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)

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 20 Ml) (ACTIVE INGREDIENTS (in each 20 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCI 10 mg 

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

• liver disease

• 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)

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

you are taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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