Mucus Relief D Tablet, Multilayer, Extended Release
FDA Label NDC 59640-300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Mucus Relief D (NDC 59640-300). 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 active ingredients (in each extended-release bi-layer tablet), purposes, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Extended-Release Bi-Layer Tablet)

Guaifenesin 1200 mg

Pseudoephedrine HCl 120 mg

Purposes

Expectorant

Nasal 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

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.

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)

When Using This Product

  • do not use more than directed

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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Other Information

  • do not use if printed blister unit is broken or torn
  • store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Package/Label Principal Display Panel

Compare to Maximum Strength Mucinex® D active ingredients

H-E-B®

Maximum Strength

Mucus Relief D

Guaifenesin 1200 mg

Pseudoephedrine Hydrochloride 120 mg

Extended-Release Bi-Layer Tablets

Expectorant / Nasal Decongestant

• Clears Nasal/Sinus Congestion

• Thins and Loosens Mucus

• Immediate and Extended Release

12 Hours

Actual Size

24 EXTENDED-RELEASE BI-LAYER TABLETS

34g-1f-mucus-relief-d (Image 01)

34g-1f-mucus-relief-d (Image 01)

* Please review the disclaimer below.