Label: AKIN- guaifenesin solution

  • NDC Code(s): 69822-200-02
  • Packager: Southern Sales & Service, 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 April 27, 2017

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

  • PURPOSE

    Expectorant
    SUGAR FREE / ALCOHOL

  • DESCRIPTION

    Each 5 mL (1 teaspoonful) contains:
    Guaifenesin 100 mg

  • Inactive Ingredients

    Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potasium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD &C Red # 40 ,caramel color,purified water.

  • USES

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

  • WARNINGS

    Ask a doctor before use if you have

    • cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with 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 headache that lasts. These could be signs of a serious condition.
    • you are hypersensitive to any of the ingredients.

    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 take more than 6 doses in any 24-hour period.
    adults and children 12 years and over2 to 4 teaspoonfuls every 4 hours or as directed by doctor.
    children under 12 yearsdo not use
  • STORAGE

    Store at room temperature, 15°-30°C (59°-86°F).

  • PRINCIPAL DISPLAY PANEL

    AKIN Cough Formula

  • INGREDIENTS AND APPEARANCE
    AKIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MENTHOL (UNII: L7T10EIP3A)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-200-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/01/2015
    Labeler - Southern Sales & Service, Inc. (013114906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Southern Sales & Service, Inc.013114906LABEL(69822-200)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(69822-200)