TUSSIN ADULT MUCUS AND CHEST CONGESTION (GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]

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TUSSIN ADULT MUCUS AND CHEST CONGESTION (GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0389-4, 49580-0389-5
Set ID c047f474-3a91-43be-8a20-05af77c1aef8
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each 10 mL)

    Guaifenesin 200 mg

  • Purposes

    Expectorant

  • 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 occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    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 (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • this adult product is not intended for use in children under 12 years of age
    • adult and children 12 years and over: 10 to 20 mL every 4 hours
    • children under 12 years: do not use
  • Other information

    • each 10 mL contains: sodium 4 mg 
    • store between 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, caramel, FD&C red #40, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredients in Robitussin® Mucus+Chest Congestion Original*

    adult

    tussin

    mucus + chest congestion

    guaifenesin 200mg

    expectorant

    relievies:

    • mucus
    • chest congestion

    for ages 12 & over

    non-drowsy

    alcohol free

    FL OZ (mL)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin®Mucus+ Chest Congestion original.

    TAMPER EVIDENT: DO NOT USE IF PRINTED  SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

    Manufactured by:

    PL Developments

    11865 S. Alameda St

    Lynwood, CA 90262

  • Package Label

    Guaifenesin 200 mg

    ReadyinCase Adult Tussin Mucus & Chest Congestion

  • INGREDIENTS AND APPEARANCE
    TUSSIN  ADULT MUCUS AND CHEST CONGESTION
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0389
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CARAMEL (UNII: T9D99G2B1R)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0389-41 in 1 BOX02/28/2015
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:49580-0389-5118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/28/2015
    Labeler - P & L Development, LLC (101896231)
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