Label: THERAFLU RELIEF MAX STRENGTH DAYTIME- acetaminophen, dextromethorphan hbr powder, for solution

  • 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 May 4, 2023

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

  • Active ingredients (each packet)

    Acetaminophen 1000 mg

    Dextromethorphan HBr 30 mg

  • Purposes

    Pain reliever/Fever reducer

    Cough suppressant

  • Uses

    temporarily relieves these symptoms due to a common cold:
    headache
    minor aches and pains
    cough due to minor throat and bronchial irritation
    minor sore throat pain
    temporarily reduces fever
  • 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 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
    a breathing problem such as emphysema or chronic bronchitis
    cough that occurs with too much phlegm (mucus)
    cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    pain or cough gets worse or lasts more than 7 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present
    new symptoms occur
    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 at 1-800-222-1222. 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
    take every 6 hours, while symptoms persist
    do not take more than 3 packets in 24 hours unless directed by a doctor
     
    Age
     
    Dose
     
    adults and children 12 years of age and over
     
    One packet
     
    children under 12 years of age
     
    do not use
    dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume the entire drink within 10-15 minutes.
    if using a microwave, add contents of one packet to 8 oz. of cool water: sip briskly before and after heating.
    do not overheat.
  • Other information

    each packet contains: potassium 6 mg
    store at room temperature. Protect from excessive heat and moisture.
  • Inactive ingredients

    anhydrous citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    *Compare to the active ingredients in Theraflu Multi-Symptom Flu Relief Max Strength** Daytime

    NDC 51316-539-06

    Daytime

    Flu Relief

    MAX STRENGTH**

    Acetaminophen - Pain Reliever/Fever Reducer

    Dextromethorphan HBr - Cough Suppressant

    Honey Lemon Flavor

    1 SINGLE DOSE

    *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Flu Relief Max Strength** Daytime.

    **Maximum Strength per 6 hour dose

    Manufactured by:

    Raritan Pharmaceuticals,

    8 Joanna Court, East Brunswick, NJ 08816

    Flu Relief  Multi-Symptom Daytime
  • INGREDIENTS AND APPEARANCE
    THERAFLU RELIEF MAX STRENGTH  DAYTIME
    acetaminophen, dextromethorphan hbr powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-539
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARAMEL (UNII: T9D99G2B1R)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorHONEY (Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-539-061 in 1 PACKET; Type 0: Not a Combination Product04/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/17/2023
    Labeler - CVS PHARMACY (062312574)