Label: FLU RELIEF THERAPY NIGHT TIME- acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride liquid 

  • Label RSS
  • 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 03/13

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

  • Active Ingredients

    Acetaminophen  325 mg
    Diphenhydramine HCl  12.5 mg
    Phenylephrine HCI  5 mg

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  • Purposes

    Acetaminophen..........................Pain reliever/fever reducer
    Diphenhydramine HCl...............Antihistamine/Cough suppressant
    Phenylephrine HCI.....................Nasal decongestant

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  • Uses

    temporarily relieves
    • minor aches and pains • sneezing
    • headache • minor sore throat pain
    • nasal and sinus congestion
    • cough due to minor throat and
    bronchial irritation • runny nose
    • itchy, watery eyes • itchy nose or
    throat • temporarily reduces fever

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  • Warnings

    Alcohol warning: If you consume
    3 or more alcoholic drinks every day,
    ask your doctor whether you should
    take acetaminophen or other pain
    relievers/fever reducers.
    Acetaminophen may cause liver
    damage.
    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

    • to make a child sleepy
    • if you are on a sodium-restricted
    diet • 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 two
    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.
    • with any other product containing
    diphenhydramine, even one used
    on skin • with any other
    acetaminophen containing
    products. This may lead to an
    overdose,which may cause liver
    damage. (see overdose warning)

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  • Ask a doctor

    • glaucoma • heart disease
    • thyroid disease • diabetes
    • high blood pressure • persistent
    or chronic cough such as occurs
    with smoking, asthma or
    emphysema • cough accompanied
    by excessive phlegm (mucus)
    • trouble urinating due to enlarged
    prostate gland
    • a breathing problem such as
    emphysema or chronic bronchitis

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  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

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  • When using this product

    • do not use more than directed
    (see overdose warning)
    • 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

    • redness or swelling is present
    • you get nervous, dizzy or sleepless
    • pain, cough or nasal congestion
    gets worse or lasts more than
    7 days • fever gets worse or lasts
    more than 3 days • new symptoms
    occur • sore throat is severe,
    persists for more than 2 days, is
    accompanied or followed by fever,
    headache, rash, nausea, or
    vomiting • cough comes back or
    occurs with rash or headache that
    lasts. These could be signs of a
    serious condition.

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  • If pregnant or breast-feeding

    ask a health professional before use.

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  • Keep this and all drugs out of the reach of children.

    Overdose Warning: Taking more
    than the recommended dose
    (overdose) could cause serious
    health problems, including liver
    damage. In case of accidental
    overdose, seek professional
    assistance or contact a Poison
    Control Center immediately. Quick
    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 exceed recommended
    dosage (see overdose warning)
    • do not use in infants

    age dose
    adults and children 12 years and over...................2 tablespoons (30 mL) every 4 hours
    children 4 years to under 12 years..........................do not use unless directed by a doctor
    children under 4 years..............................................do not use

    Do not take more than 6 doses
    (12 tablespoons) in 24 hours.

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  • Other Information

    • sodium content
    per tablespoon:
    7 mg
    • potassium content
    per tablespoon:
    5 mg
    • store at controlled room temperature

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  • Inactive Ingredients

    acesulfame potassium, alcohol,
    blue 1, citric acid, edetate disodium,
    flavors, glycerin, maltitol solution,
    propylene glycol, purified water,
    red 40, sodium benzoate,
    sodium citrate

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    FLU RELIEF THERAPY NIGHT TIME 
    theraflu nighttime liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-154
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 325 mg  in 15 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    Acesulfame Potassium  
    Alcohol  
    CITRIC ACID MONOHYDRATE  
    Edetate Disodium  
    Glycerin  
    Maltitol  
    Propylene Glycol  
    Water  
    Sodium Benzoate  
    Sodium Citrate  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    Product Characteristics
    Color red (red) Score     
    Shape Size
    Flavor CHERRY (Theraflu Type Cherry Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-154-08 245 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/2009
    Labeler - CVS (062312574)
    Registrant - Aaron Industries, Inc. (113044205)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 113044205 manufacture(59779-154), analysis(59779-154)
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