TUSSIN (GUAIFENESIN) LIQUID [APTAPHARMA INC.]

TUSSIN (GUAIFENESIN) LIQUID [APTAPHARMA INC.]
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NDC 76281-309-26
Set ID dc555299-2da9-41cf-8beb-20fe1c03c070
Category HUMAN OTC DRUG LABEL
Packager AptaPharma Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 10 mL)
    Guaifenesin, USP               200 mg

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Uses
    Helps loosen phlegm (mucus) and thin bronchial secretions to rid
    the bronchiai 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 chromc such as occurs with smoking,
    asthma, chronic bronchitis, or emphysema

  • WHEN USING

    When using this product
    • do not use more than directed

  • STOP USE

    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
    • mL = milliliter
    Age                                    Dose
     Adults & Children 12 years & over 10 mL to 20 mL every 4 hours
     Children under 12 years  Do not use

  • OTHER SAFETY INFORMATION

    Other information
    • each 10 mL contains: sodium 3mg
    • store between 20-25oC (68-77oF)
    • do not refrigerate
    • dosing cup provided

  • INACTIVE INGREDIENT

    Inactive ingredients
    Anhydrous citric acid, flavor, purified water,
    sodium benzoate, sucrose

  • QUESTIONS

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

  • Principal Display Panel

    cvs
    HealthTM

    Non-Drowsy
    Tussin
    ADULT CHEST
    CONGESTION

    Free of alcohol, dyes &
    artificial sweeteners

    GUAIFENESIN ORAL
    SOLUTION, USP
    Expectorant

    Relieves:
    • Chest Congestion
    • Mucus

    For Ages
    12 & Over

    Cherry Flavor

    8 FL OZ (237 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    DO NOT REFRIGERATE. STORE AT ROOM TEMPERATURE.

    Lot:
    Exp:

    LR-107 REV 01 #339365

    0 50428 61625 3


    CONTINUED
    ON BACK

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2019 CVS/pharmacy
    CVS.com* 1-800-SHOP CVS
    V-34690

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       Money Back Guarantee

    Tusin 309-26

    res

  • INGREDIENTS AND APPEARANCE
    TUSSIN 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-309
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-309-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-309)

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