Label: TUSSIN- guaifenesin solution

  • NDC Code(s): 70677-1186-1, 70677-1186-2
  • Packager: Strategic Sourcing Services
  • 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 August 17, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT(S)


    Guaifenesin, USP 200 mg

  • PURPOSE


    Expectorant

  • USE(S)


    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

  • WHEN USING THIS PRODUCT


    ■ do not use more than directed

  • STOP USE AND ASK 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


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

  • DIRECTIONS

    ■ do not take more than 6 doses in any 24-hour period.
    ■ this adult strength product is not intended for use in children under 12 years of age
    ■ mL = milliliter
    ■ measure only with dosing cup provided
    ■ keep dosing cup with product


    Age
    		Dose
    Adults and children
    12 years and over
    		10 – 20 mL
    every 4 hours
    Children under 12 years
    		do not use
  • Other information


    ■ each 10 mL contains:sodium 6 mg
    ■ store between 20-25°C (68-77°F)
    ■ do not refrigerate
    ■ Keep carton for full directions for use

  • 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 or comments?

    Call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin oral solution USP-118 mL

    Guaifenesin oral solution USP-118 mL

    Guaifenesin oral solution USP-237 mL

    Guaifenesin oral solution USP- 237 mL

  • INGREDIENTS AND APPEARANCE
    TUSSIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1186
    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
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1186-11 in 1 CARTON08/09/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70677-1186-21 in 1 CARTON08/09/2023
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/09/2023
    Labeler - Strategic Sourcing Services (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(70677-1186)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!