DAY-TIME NIGHT-TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CHAIN DRUG CONSORTIUM, LLC]

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  • DAY-TIME NIGHT-TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CHAIN DRUG CONSORTIUM, LLC]

DAY-TIME NIGHT-TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-490-40
Set ID 40033873-4d75-407d-a9a4-851216178c0e
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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  • Active ingredients for Night-Time (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan Hydrobromide 15 mg

    Doxylamine succinate 6.25 mg

  • Active ingredients for Day-Time (in each softgel)

    Acetaminophen 325 mg, USP

    Dextromethorphan Hydrobromide 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:

    • minor aches and pains
    • sore throat pain 
    • fever
    • headache
    • muscular aches
    • nasal congestion (Day-Time only)
    • runny nose and sneezing (Night-Time only)
    • cough due to minor throat and bronchial irritation(Night- Time only)
  • Warnings

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

    • more than 6 doses in 24 hours (Night-Time), which is the maximum daily amount
    • more than 6 doses in 24 hours (Day-Time), which is the maximum daily amount
    • 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, rash, nausea, or vomiting, consult a doctor promptly.

    Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms

    Do not use

    • with other drugs 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

    Ask a doctor before using if you have

    • liver disease
    • heart disease
    • asthma
    • emphysema
    • thyroid disease
    • diabetes
    • high blood pressure
    • cough with excessive phlegm (mucus)
    • breathing problems
    • chronic bronchitis
    • persistent or chronic cough
    • cough associated with smoking
    • trouble urinating due to enlarged prostate gland
    • glaucoma (Night-Time only)

    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 use more than directed, in addition when using Night-Time:
    • 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
    • do not use with other products containing acetaminophen

    Stop use and ask a doctor if

    • swelling or redness is present
    • symptoms do not get better within 7 days or are accompanied by a fever
    • you get nervous, dizzy or sleepless
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

  • Directions

    • take only as recommended (see overdose warning)
    • take Night-Time or Day-Time
     age Night-Time Day-Time
     adults and children 12 years of age and older swallow 2 softgels with water every 6 hours swallow 2 softgels with water every 4 hours
     children 4 to 12 years of age ask a doctor ask a doctor
     children under 4 years of age do not use do not use
    • If taking Night-Time and Day-Time softgels limit total to 4 doses per day
  • Other information

    • store at room temperature 15°-30°C (59°-86° F) and avoid excessive heat
    • this product does not contain phenylpropanolamine (PPA)
    • *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Dayquil® and Vicks® Nyquil®
  • Inactive ingredients

    Night-Time D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol 400 NF, *polyethylene glycol (PEG)- 600, povidone, propylene glycol USP, purified water USP, sorbitan, sorbitol and white edible ink. *May also contain

    Day-Time *butylated hydroxyanisole, *butylated hydroxytoluene, *carmine, *D&C yellow #10, FD&C Red#40, FD&C yellow #6, gelatin, glycerin USP, *mannitol, polyethylene glycol 400 NF, *polyethylene glycol 600, povidone, propylene glycol USP, purified water USP, *sodium metabisulfite, *sorbitan, *sorbitol, sorbitol special, and white edible ink. *May also contain.

  • Questions or comments?

    call toll free 1-877-753-3935

  • Principal Display Panel

    *Compare to active ingredients in Vicks® Dayquil® & Nyquil®

    SEE NEW WARNINGS INFORMATION

    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.

    DISTRIBUTED BY:

    CHAIN DRUG CONSORTIUM, LLC.

    2300 NW CORPORATE BLVD., SUITE 115

    BOCA RATON, FL 33431

  • Product Label

    Premier value day-time night-time softgels 40 count

    Multi symptom Day-Time Night-Time

  • INGREDIENTS AND APPEARANCE
    DAY-TIME NIGHT-TIME 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-490
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-490-401 in 1 CARTON; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 20 
    Part 22 BLISTER PACK 20 
    Part 1 of 2
    NIGHT-TIME 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P30;94A;35A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart341
    Part 2 of 2
    DAY-TIME 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGE (red) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code P19;95A;36A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/12/2010
    Labeler - Chain Drug Consortium, LLC (101668460)
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