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DayTime NightTime Cold/Flu (QUALITY CHOICE (Chain Drug Marketing Association))

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 CARTON (63868-011-48) * 8 CAPSULE in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK Label Information

Complete DayTime NightTime Cold/Flu Information

  • Active ingredients in Daytime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg


  • Active ingredients in Nighttime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg


  • Purpose for Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant


  • Purpose for Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine


  • Uses

    • temporarily relieves common cold and flu symptoms:
      • sore throat
      • headache
      • minor aches and pains
      • fever
      • cough due to minor throat and bronchial irritation
      • nasal congestion (Daytime only)
      • runny nose and sneezing (Nighttime only)

  • Warnings

    Liver warning: These products contain 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

    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
    • to make a child sleep (Nighttime only)
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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
    • cough that occurs with too much phlegm (mucus)
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nighttime only) chronic bronchitis 
    • glaucoma (Nighttime only)
    • diabetes (Daytime only)
    • heart disease (Daytime only)
    • thyroid disease (Daytime only)
    • high blood pressure (Daytime only)

    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Nighttime only)

    When using this product,

    do not exceed recommended dosage. In addition, when using Nighttime:

    • excitability may occur, especially in children
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if
    • nervousness, dizziness or sleeplessness occur (Daytime only)
    • pain, cough, and (for Daytime only) nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • 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: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 take more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • swallow whole; do not crush, chew, or dissolve

    Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours.

    Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours.

    • children under 12 years: do not use

  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • avoid excessive heat

  • Inactive ingredients

    Inactive ingredients in Daytime  butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol     *may contain this ingredient

    Inactive ingredients in Nighttime  D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol


  • Questions or comments?

    Call 1-248-449-9300 Monday-Friday 9AM-5PM EST


  • Principal Display Panel

    **Compare to the active ingredients in VICKS® DAYQUIL® and NYQUIL® LIQUICAPS®

    Non-Drowsy DayTime

    Multi-Symptom Relief for Cold/Flu

    Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

    Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

    NightTime

    Multi-Symptom Relief for Cold/Flu

    Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

    Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

    Softgels

    **This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® LiquiCaps®.

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI  48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.


  • Product Label

    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg, Dextromethorphan HBr 15 mg, Doxylamine succinate 6.25 mg

    Quality Choice Daytime Nighttime Cold and Flu Softgel


  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD/FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-011
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-011-48 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 4 BLISTER PACK 32 
    Part 2 2 BLISTER PACK 16 
    Part 1 of 2
    DAYTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color ORANGE Score no score
    Shape CAPSULE Size 20mm
    Flavor Imprint Code P19;95A;36A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341
    Part 2 of 2
    NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color GREEN Score no score
    Shape CAPSULE Size 20mm
    Flavor Imprint Code P30;94A;35A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 01/15/2013
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
    Registrant - P and L Development of New York Corporation (800014821)