Maximum Strength Mucinex® Sinus-max® Severe Congestion And Pain And Mucinex® Nightshift Sinus

Maximum Strength Mucinex® Sinus-max® Severe Congestion And Pain And Mucinex® Nightshift Sinus
SPL v3
SPL
SPL Set ID 75c6b92f-219f-4740-bb72-c02a927a21ff
Route
ORAL
Published
Effective Date 2022-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Dextromethorphan (20 mg) Triprolidine (2.5 mg)
Inactive Ingredients
Edetate Disodium Fd&c Blue No. 1 Anhydrous Citric Acid Fd&c Red No. 40 Propyl Gallate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Trisodium Citrate Dihydrate Xanthan Gum Ammonium Glycyrrhizate Ascorbic Acid Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-30

Description

Drug Facts


Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 20 mL)

Mucinex Sinus-Max Severe Congestion & Pain
Purposes
Acetaminophen 650mg Pain reliever
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
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.
  • 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.

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.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
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.

Other Information
  • each 20 mL contains: sodium 12 mg (Sinus-Max Severe Congestion & Pain only) and sodium 16 mg (Nightshift Sinus only)
  • store at 20-25°C (68-77°F)
  • do not refrigerate
When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Sinus only)
  • marked drowsiness may occur (Nightshift Sinus only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Sinus only)
  • avoid alcoholic drinks (Nightshift Sinus only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Sinus only)
Mucinex Nightshift Sinus
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sinus congestion and pressure
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep
Stop Use and Ask A 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma (Nightshift Sinus only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Sinus only)
  • 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 Kit Carton

DAY & NIGHT

SINUS CONGESTION & PAIN RELIEF

MAXIMUM STRENGTH*

NDC 63824-115-66

Mucinex®

SINUS-MAX®

SEVERE CONGESTION

& PAIN

Acetaminophen – Pain Reliever

Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

  • Clears Sinus Congestion
  • Relieves Headache
  • Thins & Loosens Mucus

FOR

AGES 12+

Mucinex®

NIGHTSHIFT

SINUS

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

Triprolidine HCl – Antihistamine

NIGHTTIME

RELIEF FOR A BETTER

MORNING

✓COUGH ✓FEVER ✓SORE THROAT

✓RUNNY NOSE ✓SNEEZING ✓NASAL CONGESTION

FOR

AGES 12+

TWO – 6 FL OZ (180 mL) bottles

TOTAL – 12 FL OZ (360 mL)

Mucinex Sinus Max Severe Congestion & Pain
  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Sore Throat Warning (nightshift Sinus Only)

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.

Inactive Ingredients (mucinex Nightshift Sinus)

ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nightshift Sinus only)
Inactive Ingredients (mucinex Sinus Max Severe Congestion & Pain)

anhydrous citric acid, edetate disodium, FD&C blue no.1, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient
, xanthan gum


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 20 mL)

Mucinex Sinus-Max Severe Congestion & Pain
Purposes
Acetaminophen 650mg Pain reliever
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
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.
  • 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.

Allergy Alert (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.

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Overdose Warning (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.

Other Information (Other information)
  • each 20 mL contains: sodium 12 mg (Sinus-Max Severe Congestion & Pain only) and sodium 16 mg (Nightshift Sinus only)
  • store at 20-25°C (68-77°F)
  • do not refrigerate
When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Sinus only)
  • marked drowsiness may occur (Nightshift Sinus only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Sinus only)
  • avoid alcoholic drinks (Nightshift Sinus only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Sinus only)
Mucinex Nightshift Sinus
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sinus congestion and pressure
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep
Stop Use and Ask A Doctor If (Stop use and ask a 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 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)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma (Nightshift Sinus only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Sinus only)
  • 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 Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

DAY & NIGHT

SINUS CONGESTION & PAIN RELIEF

MAXIMUM STRENGTH*

NDC 63824-115-66

Mucinex®

SINUS-MAX®

SEVERE CONGESTION

& PAIN

Acetaminophen – Pain Reliever

Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

  • Clears Sinus Congestion
  • Relieves Headache
  • Thins & Loosens Mucus

FOR

AGES 12+

Mucinex®

NIGHTSHIFT

SINUS

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

Triprolidine HCl – Antihistamine

NIGHTTIME

RELIEF FOR A BETTER

MORNING

✓COUGH ✓FEVER ✓SORE THROAT

✓RUNNY NOSE ✓SNEEZING ✓NASAL CONGESTION

FOR

AGES 12+

TWO – 6 FL OZ (180 mL) bottles

TOTAL – 12 FL OZ (360 mL)

Mucinex Sinus Max Severe Congestion & Pain (Mucinex Sinus-Max Severe Congestion & Pain)
  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Sore Throat Warning (nightshift Sinus Only) (Sore throat warning (Nightshift Sinus only))

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.

Inactive Ingredients (mucinex Nightshift Sinus) (Inactive ingredients (Mucinex Nightshift Sinus))

ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nightshift Sinus only)
Inactive Ingredients (mucinex Sinus Max Severe Congestion & Pain) (Inactive ingredients (Mucinex Sinus-Max Severe Congestion & Pain))

anhydrous citric acid, edetate disodium, FD&C blue no.1, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient
, xanthan gum


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