Mucinex Sinus-max Day And Night
FDA Label NDC 72854-204

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rb Health (us) Llc for the product Mucinex Sinus-max Day And Night (NDC 72854-204). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Otc - Purpose

Active ingredients (in each liquid gel)
Mucinex SINUS-MAX DAY
Purposes
Acetaminophen 325 mgPain reliever
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each liquid gel)
Mucinex SINUS-MAX NIGHT
Purposes
Acetaminophen 325 mgPain reliever
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves:
    • nasal congestion
    • headache
    • cough
    • minor aches and pains
    • sinus congestion and pressure
    • runny nose and sneezing (NIGHT only)
    • 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 (DAY only)

Liver Warning

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

  • more than 12 liquid gels 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.

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.

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
  • glaucoma (NIGHT only)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
  • 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
  • taking sedatives or tranquilizers (NIGHT only)

When Using This Product

  • do not use more than directed
  • excitability may occur, especially in children (NIGHT only)
  • marked drowsiness may occur (NIGHT only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
  • avoid alcoholic drinks (NIGHT only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 liquid gels in any 24-hour period
  • adults and children 12 years of age and over: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use

Other Information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat

Inactive Ingredients (Day Only)

FD&C yellow no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

Inactive Ingredients (Night Only)

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

Questions?

1-866-MUCINEX (1-866-682-4639)

Principal Display Panel - Kit Carton

Fast Dissolving Liquid Gels!

NDC 72854-204-24

MAXIMUM STRENGTH

Mucinex®
SINUS-MAX®

DAY

Acetaminophen – Pain Reliever
Dextromethorphan HBr - Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

  • ✓Relieves Sinus Pressure, Headache
    & Congestion
  • ✓Controls Cough
  • ✓Thins & Loosens Mucus
  • Actual Size

    16
    LIQUID GELS
    (Liquid Filled
    Capsules)

    NIGHT

    Acetaminophen – Pain Reliever
    Dextromethorphan HBr - Cough Suppressant
    Doxylamine Succinate - Antihistamine
    Phenylephrine HCl - Nasal Decongestant

    • ✓Relieves Nasal Congestion,
      Sinus Pressure & Pain
    • ✓Controls Cough
    • ✓Relieves Runny Nose & Sneezing
    • Actual Size

      8
      LIQUID GELS
      (Liquid Filled
      Capsules)

      FOR AGES 12+

      TOTAL 24
      LIQUID GELS

      Principal Display Panel (Kit Carton)

      Principal Display Panel (Kit Carton)

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