Label: MUCUS RELIEF MAXIMUM STRENGTH- mucus relief tablet, extended release

  • NDC Code(s): 69168-460-32, 69168-460-50
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 23, 2024

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

View All Sections
  • Active ingredient(s)

    Guaifenesin 1200 mg

  • Purpose

    Expectorant

  • Use(s)

    •  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 breastfeeding,

    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 meal

      • 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 between 20-25°C (68-77°F)
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate

  • Questions/Comments

  • Principal Display Panel

    Mucus Relief

    Mucus Relief

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF  MAXIMUM STRENGTH
    mucus relief tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-460
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code G;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-460-5050 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2024
    2NDC:69168-460-32100 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342004/23/2024
    Labeler - Allegiant Health (079501930)
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!