Mucinex® Sinus-max® Day Pressure, Pain & Cough And Mucinex Nightshift Night Sinus

Mucinex® Sinus-max® Day Pressure, Pain & Cough And Mucinex Nightshift Night Sinus
SPL v4
SPL
SPL Set ID c746953f-4b7d-4e2a-9b85-96bd6901f517
Route
ORAL
Published
Effective Date 2021-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Guaifenesin (200 mg) Triprolidine (1.25 mg)
Inactive Ingredients
Croscarmellose Sodium Crospovidone Fd&c Red No. 40 Fd&c Yellow No. 6 Aluminum Oxide Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Talc Titanium Dioxide Ferric Oxide Red Hydroxypropyl Cellulose, Unspecified Mica Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer (3:1; 45000 Mw) Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: VVV;LOGOcrescentmoonplus Shape: oval Color: red Color: yellow Size: 20 mm Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-01

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 caplet)

Mucinex Sinus-Max Day Pressure, Pain & Cough
Purposes
Acetaminophen 325 mg Pain reliever
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
Active ingredients (in each caplet)

Mucinex Nightshift Night Sinus
Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Triprolidine HCl 1.25 mg Antihistamine
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.
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 4,000 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
  • store at 20-25°C (68-77°F)
When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Night Sinus only)
  • marked drowsiness may occur (Nightshift Night Sinus only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Night Sinus only)
  • avoid alcoholic drinks (Nightshift Night Sinus only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Night Sinus only)
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.
Mucinex Nightshift Night Sinus
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sneezing
    • sinus congestion and pressure
    • runny nose
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep
Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma (Nightshift Night Sinus only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Night 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

FAST RELEASE. POWERFUL SYMPTOM RELIEF!

NDC 72854-243-20

MAXIMUM STRENGTH

Mucinex®

SINUS-MAX®

NIGHTSHIFT

DAY

PRESSURE, PAIN & COUGH

Acetaminophen – Pain Reliever

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

  • Relieves Sinus Pressure

    & Congestion
  • Relieves Headache
  • Controls Cough
  • Thins & Loosens Mucus

ACTUAL SIZE

FOR AGES 12+

12 CAPLETS

NIGHT

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

ACTUAL SIZE

FOR AGES 12+

8 CAPLETS

FAST

RELEASE

TOTAL 20 CAPLETS

Questions? 1 866 Mucinex (1 866 682 4639)

You may also report side effects to this phone number.

Mucinex Sinus Max Day Pressure, Pain & Cough
  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • cough
    • 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
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nightshift Night Sinus only)
Sore Throat Warning (nightshift Night 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.


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 caplet)

Mucinex Sinus-Max Day Pressure, Pain & Cough
Purposes
Acetaminophen 325 mg Pain reliever
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
Active ingredients (in each caplet)

Mucinex Nightshift Night Sinus
Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Triprolidine HCl 1.25 mg Antihistamine
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.
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 4,000 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)
  • store at 20-25°C (68-77°F)
When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Night Sinus only)
  • marked drowsiness may occur (Nightshift Night Sinus only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Night Sinus only)
  • avoid alcoholic drinks (Nightshift Night Sinus only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Night Sinus only)
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.
Mucinex Nightshift Night Sinus
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sneezing
    • sinus congestion and pressure
    • runny nose
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep
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
  • glaucoma (Nightshift Night Sinus only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Night 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)

FAST RELEASE. POWERFUL SYMPTOM RELIEF!

NDC 72854-243-20

MAXIMUM STRENGTH

Mucinex®

SINUS-MAX®

NIGHTSHIFT

DAY

PRESSURE, PAIN & COUGH

Acetaminophen – Pain Reliever

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

  • Relieves Sinus Pressure

    & Congestion
  • Relieves Headache
  • Controls Cough
  • Thins & Loosens Mucus

ACTUAL SIZE

FOR AGES 12+

12 CAPLETS

NIGHT

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

ACTUAL SIZE

FOR AGES 12+

8 CAPLETS

FAST

RELEASE

TOTAL 20 CAPLETS

Questions? 1 866 Mucinex (1 866 682 4639) (Questions? 1-866-MUCINEX (1-866-682-4639))

You may also report side effects to this phone number.

Mucinex Sinus Max Day Pressure, Pain & Cough (Mucinex Sinus-Max Day Pressure, Pain & Cough)
  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • cough
    • 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
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 Night Sinus only)
Sore Throat Warning (nightshift Night Sinus Only) (Sore throat warning (Nightshift Night 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.


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