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

  • 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 January 19, 2021

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

  • Active ingredients (in each packet)

    Acetaminophen, 650 mg

    Diphenhydramine hydrochloride 25 mg

    Phenylephrine hydrochloride 10 mg

  • Purposes

    Pain reliever / fever reducer

    Antihistamine / Cough Suppressant

    Nasal 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 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 a 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, 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
  • 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 fever, rash or headache that lasts. There could be signs of a serious condition.
  • If pregnant or breast- feeding,

    ask a health care professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away at 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.

  • Directions

    do not use more than directed
    take every 4 hours while symptoms persist, not to exceed 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.
  • Other information

    each packet contains: potassium 6 mg
    store at room temperature. Protect from excessive heat and moisture.
  • Inactive ingredients

    citric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

  • Questions or comments?

    Call 800-824-1706

    Monday-Friday 9am-4pm MST

  • Additional Information Listed On Other Panels

    *Compare to the active ingredients in THERAFLU® Nighttime Severe Cold &Cold

    WinCo FOODS

    Severe Cold & Cough

    Nighttime

    ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER

    DIPHENHYDRAMINE HCL - ANTIHISTAMINE/ COUGH SUPPRESSANT

    PHENYLEPHRINE HCl – NASAL DECONGESTANT

    Relieves: Nasal Congestion, Sore Throat Pain, Cough, Headache, Body Ache & Fever, Runny Nose & Sneezing

    6 PACKETS

    Honey Lemon Infused with Chamomile and White Tea Flavors

    READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

    KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

    TAMPER EVIDENT INNER UNIT

    DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

    The Supermarket Low price Leader ®

    100% SATISFACTION GUARANTEE

    Comments & Questions?

    800-824-1706 www.wincofoods.com

    DISTRIBUTED BY:

    WINCO FOODS, LLC,

    BOISE, ID 83704

    *This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU® Nighttime Severe Cold & Cough.

  • Principal Display

    WinCo FOODS Severe Cold & Cough Nighttime  Honey Lemon Infused with Chamomile & White Tea Flavors 6 Packets
  • INGREDIENTS AND APPEARANCE
    SEVERE COLD AND COUGH NIGHTTIME 
    acetaminophen, diphenhydramine, phenylephrine powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-323
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-323-066 in 1 CARTON08/01/2018
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2018
    Labeler - WinCo Foods, LLC (056098817)