Label: ADULT TUSSIN EXPECTORANT- guaifenesin liquid

  • NDC Code(s): 63868-039-04
  • Packager: Chain Drug Marketing Association, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients 
    (in each 5 mL teaspoon)

    Guaifenesin, USP 100 mg

  • PURPOSE

     Purpose

    Expectorant

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

    Ask a doctor before use if you have
    ■ cough that occurs with too much phlegm (mucus)
    ■ cough that lasts or is chronic such as occurs with
      smoking, asthma, chronic bronchitis, or
      emphysema

    When using this product
    ■ do not use more than directed

    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 condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health
    professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose,

    get medical help or contact a Poison Control center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ do not take more than 6 doses in any 24-hour period

    Age                                        Dose
     Adults and children
    12 years and over

     2-4 teaspoonfuls

    every 4 hours
     Children under 12 years do not use

  • OTHER SAFETY INFORMATION

    Other information
    ■ each 5 mL contains: sodium 3 mg
    ■ store between 20-25 ° C (68-77° F)
    ■ do not refrigerate
    ■ dosing cup provided
    ■ Keep carton for full directions for use

  • INACTIVE INGREDIENT

    Inactive ingredients
    Caramel, citric acid anhydrous, dextrose, FD&C red
    #40, flavor, glycerin, high fructose corn syrup,
    menthol, purified water, saccharin sodium, sodium
    benzoate

  • QUESTIONS

    Questions? Call weekdays from 9:30AM to 4:30
    PM EST at 1-877-798-5944

  • Product Label

    Adult                                                                     NDC 63868-039-04
    Tussin
    Expectorant
    Guaifenesin
    Oral Solution, USP

    For Ages 12 & Over

    Non-Drowsy

    • Relieves Chest
      Congestion
    • Loosens Mucus
    • For ages 12 & Over

    4 fl oz (118 mL)

    *This product is not manufactured or distributed by
    Pfizer, the distributor of Robitussin® Mucus plus
    Chest Congestion.

    Manufactured by:
    AptaPharma Inc.,
    1533 Union Ave.
    Pennsauken, NJ 08110

    Distributed by CDMA., Inc.
    43157 W 9Nine Mile
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 800-935-2362

    Tussin Crton

    Tusin Botl

    res

  • INGREDIENTS AND APPEARANCE
    ADULT TUSSIN EXPECTORANT 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-039
    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
    CARAMEL (UNII: T9D99G2B1R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRY (cherryFlavor Liquid) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-039-041 in 1 CARTON06/27/2022
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/07/2012
    Labeler - Chain Drug Marketing Association, Inc. (011920774)
    Registrant - AptaPharma, Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma, Inc.790523323manufacture(63868-039)
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