Label: THERAFLU SEVERE COLD RELIEF CHEST CONGESTION DAYTIME- acetaminophen, dextromethorphan hbr, guaifenesin syrup

  • NDC Code(s): 0067-0104-08
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 10, 2024

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  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

  • Purposes

    Pain reliever/Fever reducer

    Cough suppressant

    Expectorant

  • Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • minor sore throat pain
      • headache
      • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting consult a doctor promptly.

    Do not use

    • in a child under 12 years of age
    • if you are allergic to acetaminophen
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain or cough gets worse or lasts more than 7 days
    • cough comes back or occurs with rash or headache that lasts

    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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not use more than directed
    • measure the dose correctly using the enclosed dosing cup
    • take every 4 hours in dosing cup provided, while symptoms persist
    • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

    Age

    Dose

    Adults and children 12 years of age and over

    30 mL

    Children under 12 years of age

    do not use
  • Other information

    • each 30 mL contains: potassium 30 mg, sodium 13 mg
    • store at controlled room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions or comments?

    1-855-328-5259

  • Generic Section

    Distributed by: Haleon, Warren, NJ 07059. Made in Canada

    Trademarks are owned by or licensed to the Haleon group of companies.

    ©2023 Haleon group of companies or its licensor. Pat. Info www.productpats.com62000000207727

    PEEL BACK HERE

    DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

  • Package/Label Principal Display Panel

    MULTI-SYMPTOM COLD RELIEF

    NEW FORMULA

    THERAFLU

    SEVERE

    COLD RELIEF

    + CHEST CONFESTION

    Acetaminophen

    Pain reliever/Fever Reducer

    Dextromethorphan HBr

    Cough Suppressant

    Guaifenesin/ Expectorant

    DAYTIME FORMULA

    Powerful formula that relieves:

    / Chest congestion

    / Thins and loosens mucus

    / Head and body ache

    / Fever

    / Cough

    / Sore throat pain

    8.3 FL OZ (245.5 mL)

    Berry Flavor

    PARENTS:

    Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    62000000207725

    Theraflu SCRCC Day 8oz
  • INGREDIENTS AND APPEARANCE
    THERAFLU   SEVERE COLD RELIEF CHEST CONGESTION DAYTIME
    acetaminophen, dextromethorphan hbr, guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0104-08245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2023
    Labeler - Haleon US Holdings LLC (079944263)
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