Mucinex D
FDA Label NDC 68258-3035

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions Inc. for the product Mucinex D (NDC 68258-3035). 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 uses, directions, other information, inactive ingredients, how supplied, principal display panel - 600 mg carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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 934P, NF; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

How Supplied

Mucinex®D is supplied by Dispensing Solutions Inc. as follows:

NDCStrengthQuantity/FormColorSource NDC
68258-3035-1600 mg / 60 mg18 TabletsWHITE63824-057-18

This product was:

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224

And Relabeled By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

Principal Display Panel - 600 Mg Carton

NDC 68258-3035-1

Mucinex®D

600 mg guaifenesin & 60 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT & NASAL DECONGESTANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Clears Nasal/Sinus Congestion

18 EXTENDED-RELEASE BI-LAYER TABLETS

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