DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [P & L DEVELOPMENT, LLC]

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  • DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [P & L DEVELOPMENT, LLC]

DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [P & L DEVELOPMENT, LLC]
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NDC 59726-072-48
Set ID 9eee551c-0bf8-4351-a0f2-68af9fc51eb7
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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  • 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

    DAYTIME

    • temporarily relieves common cold and flu symptoms
      • cough due to minor throat and bronchial irritation
      • nasal condition
      • headache
      • minor aches and pains
      • fever
      • sore throat

    NIGHTTIME

    • temporarily relieves common cold and flu symptoms
      • cough due to minor throat and bronchial irritation
      • sore throat
      • headache
      • minor aches and pains
      • fever
      • runny nose & sneezing
  • Warnings

    DAYTIME NIGHTTIME

    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

    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

    DAYTIME NIGHTTIME

    • 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

    DAYTIME

    • liver disease
    • heart disease
    • diabetes
    • thyroid disease
    • high blood pressure
    • cough that occurs with too much phlegm (mucus)
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occur with smoking, asthma, or emphysema

    NIGHTTIME

    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • trouble urinating due to an enlarged prostate gland 

    Ask a doctor or pharmacist before use if you are

    DAYTIME

    • taking the blood thinning drug warfarin.

    NIGHTTIME

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product,

    DAYTIME

    do not use more than directed.

    NIGHTTIME

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

    Stop use and ask a doctor if

    DAYTIME

    • nervousness, dizziness, or sleeplessness occur
    • pain, cough, or nasal congestion gets worse or lasts more than 7 days
    • redness or swelling is present
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.

    NIGHTTIME

    • pain or cough 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.

    DAYTIME NIGHTTIME

    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 between 15°-30°C (59°-86°F)
    • avoid excessive heat
  • Inactive ingredients

    Daytime butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow #10*, edible white ink, FD&C red #40*, FD&C yellow #6*, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, sorbitol   

    *may contain this ingredient

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

    *may contain this ingredient

  • Questions or comments?

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

  • Principal Display Panel

    DAYTIME

    daytime

    Multi-Symptom Cold & Flu Relief

    acetaminophen (pain reliever / fever reducer)

    dextromethorphan HBr (cough suppressant)

    phenylephrine HCl (nasal decongestant)

    • non-drowsy
    • alcohol-free
    • antihistamine

    softgels**

    (**liquid-filled capsules)

    NIGHTTIME

    nighttime

    multi-symptom cold & flu relief

    acetaminophen (pain reliever / fever reducer)

    dextromethorphan HBr (cough suppressant)

    doxylamine succinate (antihistamine)

    • alcohol-free

    softgels

    (**liquid-filled capsules)

    When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

    †Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®

    *This product is not manufactured or distributed by The Procter & Gamble Company, Vicks® DayQuil® and NyQuil® LiquiCaps® are registered trademarks of The Procter and Gamble Company.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by: PL Developments

    200 Hicks Street, Westbury, NY 11590

  • Product Label

    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg

    WELLNESS BASICS Daytime Nighttime Multi-Symptom Cold and Flu Relief

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD AND FLU RELIEF  MULTI-SYMPTOM
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-072
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-072-481 in 1 KIT; Type 0: Not a Combination Product12/31/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 16 
    Part 21 BLISTER PACK 32 
    Part 1 of 2
    NIGHTTIME COLD AND FLU 
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P30;94A;215;P120;SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 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
    DAYTIME COLD AND FLU 
    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 HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P19;95A;512;P19
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    132 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/31/2017
    Labeler - P & L Development, LLC (800014821)
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