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

  • NDC Code(s): 55319-964-51, 55319-964-91
  • Packager: Family Dollar Services 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 November 8, 2021

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

  • Active ingredient (in each packet)

    Acetaminophen 650 mg

    Diphenhydramine hydrochloride 25 mg

    Phenylephrine hydrochloride 10 mg

  • Purpose

    Pain reliever/fever reducer

    Antihistamine/Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves
    minor aches and pains
    minor sore throat
    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 6 packets in 24 hours, which is the maximum daily amount for this product
    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.

    Do not use

    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.
    to make a child sleepy

    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, 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
    a sodium-restricted diet

    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 use more than directed
    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

    you get nervous, dizzy or sleepless
    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 fever, 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. (1-800-222-1222) Quick 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 – see Liver warning
    take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
    adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    children under 12 years of age: consult a doctor
    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 and sodium 24 mg
    phenylketonurics: contains phenylalanine 13 mg per packet
    store at 20º-25ºC (68º-77ºF)
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENTS OF THERAFLU® SEVERE COLD & COUGH NIGHTTIME

    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

    Headache

    Sore Throat Pain

    Fever

    HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS

    Flu & Severe Cold & Cough Carton Image 1
    Flu & Severe Cold & Cough Carton Image 2
  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS FLU AND SEVERE COLD AND COUGH  NIGHTTIME
    acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-964
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-964-916 in 1 CARTON; Type 0: Not a Combination Product11/16/2017
    2NDC:55319-964-518 in 1 CARTON; Type 0: Not a Combination Product11/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/16/2017
    Labeler - Family Dollar Services Inc (024472631)