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

  • NDC Code(s): 68163-541-06
  • Packager: RARITAN PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL

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 September 1, 2023

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  • 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 No. 6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panels

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

    NDC# 68163-541-06

    Nighttime

    Severe Cold & Cough

    ACETAMINOPHEN

    PAIN RELIEVER/FEVER REDUER

    DIPHENHYDRAMINE HCl

    ANTIHISTAMINE/ COUGH SUPPRESSANT

    PHENYLEPHRINE HCl

    NASAL DECONGESTANT

    •
    Aspartame free
    •
    Sodium Free

    Relieves:

    Body Ache & Fever

    •
    Cough
    •
    Fever
    •
    Headache
    •
    Nasal Congestion
    •
    Runny Nose
    •
    Sneezing
    •
    Sore Throat Pain

    6 PACKETS

    Honey Lemon Flavor

    Infused with Chamomile & White Tea Flavors

    TAMPER EVIDENT: DO NOT USE IF INNER SEALED PACKET IS TORN

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court

    East Brunswick, NJ 08816

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

  • Display

    DRx Nighttime Severe Cold and Cough Honey Lemon Flavor
  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SEVERE COLD AND COUGH 
    acetaminophen, diphenhydramine, phenylephrine powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-541
    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:68163-541-066 in 1 CARTON03/22/2019
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/22/2019
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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