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

  • NDC Code(s): 63868-291-06
  • Packager: Chain Drug Manufacturing Assn
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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
    • symptoms do not get better or worsen
    • 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

    children under 12 years of age

    do not use unless directed by a doctor

    adults and children 12 years of age and over

    one packet

    • 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?

    1-866-467-2748

  • Additional Information Listed On Other Panels

    QC Quality Choice

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

    Severe Cold & Cough

    Nighttime

    Acetaminophen -Pain Reliever/ Fever Reducer

    Diphenhydramine HCl - Antihistamine/ Cough Suppressant

    Phenylephrine HCl - Nasal Decongestant

    Aspartame Free● Sodium Free

    • Relieves :
    • Nasal Congestion ǀ Cough ǀ Runny Nose ǀ Sneezing ǀ Body Ache ǀ Sore Throat Pain ǀ Headache ǀ Fever.

    Honey Lemon Infused with Chamomile and White Tea Flavors

    6 Packets

    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.

    Distributed by: C.D.M.A., Inc ©

    43157 W. 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 248-449-9300

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

  • Principal Display

    Quality Choice Severe Cold and Cough Nighttime 6 Packets
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE SEVERE COLD AND COUGH NIGHTTIME 
    acetaminophen, diphenhydramine, phenylephrine powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-291
    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:63868-291-066 in 1 CARTON07/16/2018
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/16/2018
    Labeler - Chain Drug Manufacturing Assn (011920774)