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

  • Label RSS
  • NDC Code(s): 0043-6256-06
  • Packager: Novartis Consumer Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • Active ingredient

    Acetaminophen, 650 mg

    Diphenhydramine hydrochloride, 25 mg

    phenylephrine hydrochloride, 10 mg

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  • Purpose

    Pain reliever / fever reducer

    Antihistamine / cough suppressant

    Nasal decongestant

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  • Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • minor sore throat pain
      • headache
      • nasal and sinus congestion
      • runny nose or throat
      • itchy, watery eyes due to hay fever
      • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
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  • Warnings

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

    • more than 6 packets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

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  • Do not use

    • in a child under 4 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 a 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.
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  • Ask Doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • a sodium-restricted diet
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema, asthma 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
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  • Ask a doctor or pharmacist before use if you are taking

    • sedatives or tranquilizers
    • the blood thinning drug warfarin
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  • 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
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  • 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
    • symptoms do not get better or worsen
    • pain, cough or nasal congestion gets worse or lasts more than 7 days
    • cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.
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  • If pregnant or breast- feeding,

    ask a health care professional before use.

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  • 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.

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  • Directions

    • do not use more than directed
    • take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor

    Age

    Dose

    children under 4 years of age

    do not use

    children 4 to under 12 years of age

    do not use unless directed by a doctor

    adults and children 12 years of age and over

    one packet

    • 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.
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  • Other information

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

    acesulfame K, aspartame, citric acid, D&C yellow#10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

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  • Questions or Comments?

    call 1-800-452-0051

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  • Additional Information Listed On Other Panels

    Theraflu®

    Nighttime

    Severe Cold & Cough

    ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

    DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT

    PHENYLEPHRINE HCl – NASAL DECONGESTANT

    • Nasal Congestion
    • Cough
    • Runny Nose
    • Sneezing
    • Body Ache
    • Sore Throat Pain
    • Headache
    • Fever
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  • Principal Display
  • INGREDIENTS AND APPEARANCE
    THERAFLU  NIGHTTIME SEVERE COLD AND COUGH
    acetaminophen, diphenhydramine, phenylephrine powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0043-6256
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    ASPARTAME  
    CITRIC ACID MONOHYDRATE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    HONEY  
    LEMON  
    MALTODEXTRIN  
    SILICON DIOXIDE  
    SODIUM CITRATE  
    SUCROSE  
    TRIBASIC CALCIUM PHOSPHATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0043-6256-06 6 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/24/2012
    Labeler - Novartis Consumer Health (129836151)
    Registrant - Novartis Consumer Health, Inc. (879821635)
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