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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2025

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
    1. Age
    1. Dose
    1. adults and children 12 years of age and over
    1. One packet
    1. children under 12 years of age
    1. 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 DrugM01204/17/2023
    Labeler - CVS PHARMACY (062312574)