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DayTime Nighttime multi symptom cold and flu relief (Shopko Stores Operating Co., LLC.)

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 CARTON (37012-490-48) * 8 CAPSULE in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK Label Information

Complete DayTime Nighttime multi symptom cold and flu relief Information

  • Active ingredients for Nighttime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg


  • Active ingredients for Daytime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg


  • Purpose for Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine


  • Purpose for Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant


  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing (Nighttime only)
    • nasal congestion (Daytime only)

  • Warnings

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 4 doses in 24 hours, which is the maximum daily amount for these products
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using these products

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
    • 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 sleep (Nighttime only)

    Ask a doctor before use if you have
    • liver disease
    • heart disease (Daytime only)
    • thyroid disease (Daytime only)
    • diabetes (Daytime only)
    • high blood pressure (Daytime only)
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland
    • glaucoma (Nighttime only)

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

    When using these products
    • do not use more than directed

    In addition, when using Nighttime:

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

    Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless (Daytime only)
    • redness or swelling is present
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • symptoms do not get better within 7 days or are accompanied by a fever
    • cough lasts more than 7 days, 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.

    Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms


  • Directions

    • take only as directed – see overdose warning
    • take Nighttime OR Daytime

    Nighttime Softgels

    • do not exceed 4 doses per 24 hours
     adults and children 12 years and over  swallow 2 softgels with water every 6 hours
     children 4 to under 12 years  ask a doctor
     children under 4 years  do not use

    Daytime Softgels

    • do not exceed 4 doses per 24 hours
     adults and children 12 years and over  swallow 2 softgels with water every 4 hours
     children 4 to under 12 years  ask a doctor
     children under 4 years  do not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

  • Other information

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

  • Inactive ingredients

    Nighttime D&C Yellow #10, edible white printing ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol NF, povidone, propylene glycol, purified water, sorbitan, and sorbitol

    Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white printing ink, FD&C Red #40*, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, and sorbitol

    *may contain this ingredient


  • Questions or comments?

    call 1-877-753-3935 Monday- Friday 9AM- 5PM EST


  • Principal Display Panel

    **Compare to Vicks® Nyquil® and Vicks® Dayquil® active ingredients

    **These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® and Vicks® Dayquil®

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    Packaged by: PL Developments

    200 Hicks street Westbury

    NY 11590, USA


  • Product Label

    shopko daytime nighttime cold and flu relief

    daytime nighttime cold and flu relief


  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-490
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37012-490-48 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 BLISTER PACK 16 
    Part 2 4 BLISTER PACK 32 
    Part 1 of 2
    NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, 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 21mm
    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
    Part 2 of 2
    DAYTIME 
    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 15 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 19mm
    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 05/10/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 05/10/2012
    Labeler - Shopko Stores Operating Co., LLC. (023252638)