Mucosan Max With Acetaminophen

Mucosan Max With Acetaminophen
SPL v2
SPL
SPL Set ID 26a4861b-5d8e-9ec6-e063-6394a90af577
Route
ORAL
Published
Effective Date 2024-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

Active Ingredients (in each 20 mL) Purpose Acetaminophen, 650 mg................................Pain reliever/Fever reducer Dextromethorphan HBr, 20 mg......................Cough suppressant Guaifenesin, 400 mg.............................. .......Expectorant Phenylephrine HCl, 10 mg.............................Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings

Liver warning:this product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4 doses (20 mL each) in 24 hours, wich is the maximum daily amount for this product
  • 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 and rash. If 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.

Indications and Usage

Uses

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlem (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage and Administration

Directions

  • do not take more than direct
  • do not take more than 4 doses in any 24 hours
  • this adult strength product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • dose as follows

age dose
adults and children 12 years of age and older 20 mL every 4 hours
children under 12 years of age do not use

Description

Active Ingredients (in each 20 mL) Purpose Acetaminophen, 650 mg................................Pain reliever/Fever reducer Dextromethorphan HBr, 20 mg......................Cough suppressant Guaifenesin, 400 mg.............................. .......Expectorant Phenylephrine HCl, 10 mg.............................Nasal Decongestant

Section 34088-5

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 even if you do not notice any signs or symptoms.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough comes back or occurs with fever, rash, or persistant headache
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur. These could be signs of a serious condition.
Section 50567-7

When using this product do not use more than direct.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urination due to enlarged prostate gland.
Section 50570-1

Do not use

  • With any other drug containing acetamonophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are 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 a MAOI, ask a doctor or Pharmacist before taking this product.
Section 51727-6

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

Section 51945-4

Section 53413-1

Questions or comments?

1-800-560-5223Monday to Friday 9am-4pm, Eastern Time

Section 53414-9

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

Section 55105-1

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients (in each 20 mL) Purpose

Acetaminophen, 650 mg................................Pain reliever/Fever reducer

Dextromethorphan HBr, 20 mg......................Cough suppressant

Guaifenesin, 400 mg.............................. .......Expectorant

Phenylephrine HCl, 10 mg.............................Nasal Decongestant

Section 60561-8

Other information

  • each (20 mL) contains:sodium 10mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlem (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage and Administration (34068-7)

Directions

  • do not take more than direct
  • do not take more than 4 doses in any 24 hours
  • this adult strength product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • dose as follows

age dose
adults and children 12 years of age and older 20 mL every 4 hours
children under 12 years of age do not use

Warnings and Precautions (34071-1)

Warnings

Liver warning:this product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4 doses (20 mL each) in 24 hours, wich is the maximum daily amount for this product
  • 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 and rash. If 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.

Section 34088-5 (34088-5)

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 even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough comes back or occurs with fever, rash, or persistant headache
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur. These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product do not use more than direct.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urination due to enlarged prostate gland.
Section 50570-1 (50570-1)

Do not use

  • With any other drug containing acetamonophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are 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 a MAOI, ask a doctor or Pharmacist before taking this product.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-560-5223Monday to Friday 9am-4pm, Eastern Time

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients (in each 20 mL) Purpose

Acetaminophen, 650 mg................................Pain reliever/Fever reducer

Dextromethorphan HBr, 20 mg......................Cough suppressant

Guaifenesin, 400 mg.............................. .......Expectorant

Phenylephrine HCl, 10 mg.............................Nasal Decongestant

Section 60561-8 (60561-8)

Other information

  • each (20 mL) contains:sodium 10mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate.

Advanced Ingredient Data


Raw Label Data

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