Mucinex D Tablet, Extended Release
FDA Label NDC 50090-1076

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Mucinex D (NDC 50090-1076). 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, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Reckitt Benckiser
Parsippany, NJ 07054-0224
© 2012 RB

Otc - Purpose

Active ingredients (in each extended-release bi-layer tablet)Purpose
Guaifenesin 600 mgExpectorant
Pseudoephedrine HCl 60 mgNasal Decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • temporarily relieves sinus congestion and pressure

Otc - Do Not Use

Do not use 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.

Otc - Ask Doctor

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Otc - When Using

When using this product

  • do not use more than directed

Otc - Stop Use

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
  • children under 12 years of age: do not use

Other Information

  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store at 20-25°C (68-77°F)

Inactive Ingredients

Carbomer homopolymer type B; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

How Supplied

Product: 50090-1076

NDC: 50090-1076-0 9 TABLET, EXTENDED RELEASE in a BLISTER PACK

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