Label: THERAFLU NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution

  • 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, 2022

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


    Drug Facts


    Active ingredients (in each packet)Purposes
    Acetaminophen 650 mgPain reliever/fever reducer
    Diphenhydramine HCl 25 mgAntihistamine/cough suppressant
    Phenylephrine HCl 10 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • minor sore throat pain
      • headache
      • nasal and sinus congestion
      • runny nose
      • sneezing
      • itchy nose or throat
      • itchy, watery eyes due to hay fever
      • cough due to minor throat and bronchial irritation
    • 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.
    • with any other product containing diphenhydramine, even one used on the skin
    • 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
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • 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 sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    • do not exceed recommended dosage
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain, cough or nasal congestion 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
    • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
      adults and children 12 years of age and overone packet
      children under 12 years of agedo not use
    • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
  • Other information

    • each packet contains: potassium 10 mg, sodium 23 mg
    • phenylketonurics: contains phenylalanine 13 mg per packet
    • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

  • Questions or comments?

    call 1-855-328-5259


    Packaged and distributed by Select Corporation with the permission of GSK Consumer Healthcare
    Warren, NJ 07059

  • PRINCIPAL DISPLAY PANEL - 20 Packet Carton





    Pain Reliever/Fever Reducer

    Diphenhydramine HCl
    Antihistamine/Cough Suppressant

    Phenylephrine HCl
    Nasal Decongestant

    Runny Nose
    Nasal Congestion
    Sore Throat Pain
    Body Ache


    20 PACKETS

    Principal Display Panel - 20 Packet Carton
    acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-898(NDC:0067-7918)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) acetaminophen650 mg  in 237 mL
    diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride25 mg  in 237 mL
    phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride10 mg  in 237 mL
    Inactive Ingredients
    Ingredient NameStrength
    acesulfame potassium (UNII: 23OV73Q5G9)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    aspartame (UNII: Z0H242BBR1)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium citrate, unspecified form (UNII: 1Q73Q2JULR)  
    sucrose (UNII: C151H8M554)  
    tribasic calcium phosphate (UNII: 91D9GV0Z28)  
    Product Characteristics
    Color    Score    
    FlavorHONEY, LEMON (honey lemon infused with chamomile & white tea flavors) Imprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-898-031 in 1 BLISTER PACK04/30/2018
    1237 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:52904-898-2020 in 1 CARTON04/30/2018
    2237 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/30/2018
    Labeler - Select Corporation (053805599)