DailyMed - MUCINEX MAXIMUM STRENGTH (2024)

  • Label RSS
  • NDC Code(s): 63824-023-02, 63824-023-07, 63824-023-18, 63824-023-35, view more

    63824-023-36, 63824-023-46, 63824-023-48, 63824-023-56

  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 16, 2022

If you are a consumer or patient please visit this version.

  • Download DRUG LABEL INFO: PDF XML
  • Official Label (Printer Friendly)

View All Sections

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release bi-layer tablet)

    Guaifenesin 1200 mg

  • Purpose

    Expectorant

  • Uses
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Do not use

    • for children under 12 years of age

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with 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.

  • Directions
    • do not crush, chew, or break tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
    • children under 12 years of age: do not use
  • Other information
    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; FD&C blue no. 1 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.

  • SPL UNCLASSIFIED SECTION

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

    Made in England

  • PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

    NDC 63824-023-35

    MAXIMUM STRENGTH

    Mucinex®
    1200 mg guaifenesin
    extended-release bi-layer tablets

    EXPECTORANT

    12
    HOUR®

    🗸
    Relieves Chest Congestion
    🗸
    Thins and Loosens Mucus
    🗸
    Immediate and Extended Release

    14
    EXTENDED-RELEASE
    BI-LAYER TABLETS

    DailyMed - MUCINEX MAXIMUM STRENGTH (2)

  • INGREDIENTS AND APPEARANCE
    MUCINEX MAXIMUM STRENGTH
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200mg
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)
    FD&C blue no. 1 (UNII: H3R47K3TBD)
    aluminum oxide (UNII: LMI26O6933)
    hypromellose, unspecified (UNII: 3NXW29V3WO)
    magnesium stearate (UNII: 70097M6I30)
    microcrystalline cellulose (UNII: OP1R32D61U)
    Product Characteristics
    ColorWHITE (blue and white) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code Mucinex;1200
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-023-071 in 1 CARTON06/11/2015
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63824-023-351 in 1 CARTON06/26/2012
    214 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63824-023-362 in 1 CARTON06/26/2012
    314 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:63824-023-484 in 1 CARTON06/26/2012
    412 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:63824-023-463 in 1 CARTON06/26/2012
    514 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:63824-023-182 in 1 CARTON06/26/201206/15/2022
    69 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:63824-023-021 in 1 CARTON07/01/2021
    71 in 1 POUCH; Type 0: Not a Combination Product
    8NDC:63824-023-564 in 1 CARTON07/01/2021
    814 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02128206/26/2012

    Labeler -RB Health (US) LLC(081049410)

View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!

View Labeling Archives for this drug

MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release

Number of versions: 11

Published Date (What is this?) Version Files
Jun 20, 2022 13 (current) download
Apr 14, 2021 12 download
May 21, 2019 11 download
Aug 9, 2016 10 download
Dec 21, 2015 9 download
Jun 19, 2015 8 download
Oct 10, 2014 7 download
Jul 24, 2012 6 download
Jan 4, 2012 5 download
Jun 29, 2011 4 download
Dec 29, 2009 1 download

RxNorm

MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release

RxCUI RxNorm NAME RxTTY
1 310621 guaiFENesin 1200 MG 12HR Extended Release Oral Tablet PSN
2 310621 12 HR guaifenesin 1200 MG Extended Release Oral Tablet SCD
3 310621 guaifenesin 1200 MG 12 HR Extended Release Oral Tablet SY
4 891297 Mucinex 1200 MG 12HR Extended Release Oral Tablet PSN
5 891297 12 HR guaifenesin 1200 MG Extended Release Oral Tablet [Mucinex] SBD
6 891297 Mucinex 1200 MG 12 HR Extended Release Oral Tablet SY

Get Label RSS Feed for this Drug

MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release

To receive this label RSS feed

Copy the URL below and paste it into your RSS Reader application.

https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=47f5323c-ee3a-400d-b133-31d9c286fafd

To receive all DailyMed Updates for the last seven days

Copy the URL below and paste it into your RSS Reader application.

https://dailymed.nlm.nih.gov/dailymed/rss.cfm

What will I get with the DailyMed RSS feed?

DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.

How to discontinue the RSS feed

If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?


Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

NDC Codes

MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 63824-023-02
2 63824-023-07
3 63824-023-18
4 63824-023-35
5 63824-023-36
6 63824-023-46
7 63824-023-48
8 63824-023-56
DailyMed - MUCINEX MAXIMUM STRENGTH (2024)

References

Top Articles
Latest Posts
Recommended Articles
Article information

Author: Rev. Porsche Oberbrunner

Last Updated:

Views: 5862

Rating: 4.2 / 5 (53 voted)

Reviews: 84% of readers found this page helpful

Author information

Name: Rev. Porsche Oberbrunner

Birthday: 1994-06-25

Address: Suite 153 582 Lubowitz Walks, Port Alfredoborough, IN 72879-2838

Phone: +128413562823324

Job: IT Strategist

Hobby: Video gaming, Basketball, Web surfing, Book restoration, Jogging, Shooting, Fishing

Introduction: My name is Rev. Porsche Oberbrunner, I am a zany, graceful, talented, witty, determined, shiny, enchanting person who loves writing and wants to share my knowledge and understanding with you.