Label: TUSSIN ADULT MUCUS AND CHEST CONGESTION- guaifenesin liquid

  • NDC Code(s): 49580-0389-4, 49580-0389-5
  • Packager: P & L Development, LLC
  • 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 June 7, 2023

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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 BOX02/28/201512/31/2025
    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 Product02/28/201512/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/28/201512/31/2025
    Labeler - P & L Development, LLC (101896231)
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Safety

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