Label: FLU AND SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution

  • NDC Code(s): 56062-964-91
  • Packager: Publix Super Markets Inc
  • 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 March 21, 2017

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

  • Active ingredients (in each packet)

    Acetaminophen 650 mg

    Diphenhydramine HCl 25 mg

    Phenylephrine HCl 10 mg

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  • Purposes

    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
    sneezing
    itchy 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 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 have ever had an allergic reaction to this product or any of its ingredients
    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 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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (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.

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  • Directions

    do not use more than directed (see overdose warning)
    take every 4 hours, while symptoms persist. Do not take more than 5 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 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 and sodium 25 mg
    phenylketonurics: contains phenylalanine 13 mg per packet
    store at 20-25 °C (68-77 °F). Protect product from heat and moisture.
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  • Inactive ingredients

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

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  • Package/Label Principal Display Panel

    NIGHTTIME

    flu & severe cold & cough

    PAIN RELIEVER-FEVER REDUCER (ACETAMINOPHEN)

    ANTIHISTAMINE/COUGH SUPPRESSANT (DIPHENHYDRAMINE HCl)

    NASAL DECONGESTANT (PHENYLEPHRINE HCl)

    nasal congestion

    cough

    runny nose

    sneezing

    body ache

    sore throat pain

    headache/fever

    6 PACKETS

    HONEY LEMON-INFUSED WITH WHITE TEA FLAVORS

    Compare to the Active Ingredients in Theraflu® Nighttime Severe Cold & Cough

    Flu & Severe Cold & Cough Carton
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  • INGREDIENTS AND APPEARANCE
    FLU AND SEVERE COLD AND COUGH 
    acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-964
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:56062-964-91 6 in 1 CARTON; Type 0: Not a Combination Product 09/29/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/29/2011
    Labeler - Publix Super Markets Inc (006922009)
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