Label: AIR POWER- guaifenesin tablet

  • NDC Code(s): 53499-0232-1
  • Packager: Schwabe North America, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 14, 2021

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

  • Active Ingredient:

    Guaifenesin 200 mg

  • INACTIVE INGREDIENTS:

    Carnauba wax, cellulose, dextrin, fenugreek seed extract, glycerin, hypromellose, magnesium stearate, maltodextrin, marshmallow root extract, mullein leaf extract, povidone, silica, sodium croscarmellose, stearic acid.

  • Dosage & Administration:


    Dosage:  Adults and Children 12 years and over:
      1-2 tabletss every 4 hours, not to exceed 12 tablets in 24 hours.
    Children 6 to 11 years of age: 1/2 to 1 tablets every 4 hours not to exceed 6 tablets in 24 hours.

    Children under 6 years of age:  consult a doctor.

    Purpose:

    Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of mucus and make coughs more productive.

    Indications & Useage:

    Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of mucus and make coughs more productive.

  • Warnings: 

    Do not use this product if you are pregnant, attempting to become pregnant, or breast-feeding. 

    Do not take this product for persistent or chronic cough such that occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompaied by excessive phlegm (mucus) unless directed by a doctor.

  • Ask a doctor before use if you have:

    Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, have a cough that is accompanied by excessive phlegm (mucus), have diabetes, are taking antibiotics or any other prescription medication. 

  • Stop Use:

    Stop use and ask a doctor if cough persists more than one week, tends to recur, or is accompanied by a fever, rash or persisient headache.
    A persistent cough may be a sign of a serious condition.

    If you are taking any medications, consult a consult a healthcare professional before use.

  • Keep out of Reach of Children:

    Keep out of the reach of children.

  • Overdosage:

    In case of overdose, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    LE02321.H05 Air-Power.jpg

  • INGREDIENTS AND APPEARANCE
    AIR POWER  
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    FENUGREEK SEED (UNII: 654825W09Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    VERBASCUM THAPSUS LEAF (UNII: ANX0EG34JE)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorbrown (light brown to gray-brown w/ light and/or dark specks) Scoreno score
    ShapeOVAL (Convex face, debossed 232 tablet) Size20mm
    FlavorImprint Code 232
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-0232-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/14/2021
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-0232)