TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]

TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-020-04, 68016-020-08
Set ID a6ce674a-df4e-4172-8171-bbab0b53c8d2
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient

    Drug Facts

    Active ingredient  
    (in each 5 mL tsp)

    Guaifenesin, USP 100 mg

  • Purpose

     Purpose

    Expectorant

  • 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.

  • Uses

    Uses

    helps to loosen phlegm (mucus)and thin bronchial secretions to rid the bronchial passage ways 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

    When using this product

    • do not use more than directed
  • Stop use and ask a doctor if

    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.

  • If pregnant or breast-feeding

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions

    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 information

    Other information

    • Keep carton for full direction for use
    • sodium 3 mg per teaspoonful
    • store between 20-25 ° C (68-77° F)
    • do not refrigerate
    • dosing cup provided
  • Inactive ingredients

    Inactive ingredients

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

  • Questions?

    Questions? 

    Call weekdays from 9:30 AM to 4:30 PM EST at

    1-877-798-5944

  • Product Label

    NDC 68016-020-04

    Premier Value®
    Tussin

    Guaifenesin Oral solution, USP

    EXPECTORANT


    Relieves Chest Congestion
    Loosens Mucus
    Non-Drowsy

    Adult
    For ages 12 and Over

    Cherry Flavor Liquid

    8 FL OZ (37 mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431

    BX-016

    AptaPharma  Tussin EXP1

  • INGREDIENTS AND APPEARANCE
    TUSSIN  EXPECTORANT
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-020
    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
    Color    Score    
    ShapeSize
    FlavorCHERRY (cherryFlavor Liquid) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-020-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2012
    2NDC:68016-020-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/07/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma, Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma, Inc.790523323manufacture(68016-020)

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