DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)]

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  • DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)]

DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)]
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NDC 41520-491-48
Set ID 196d8d95-a2db-4695-b3b5-daced8417f5b
Category HUMAN OTC DRUG LABEL
Packager Care One (American Sales Company)
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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  • Active ingredients for Daytime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Active ingredients for Nitetime (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 (Nitetime 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 (Nitetime 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 Nitetime only) chronic bronchitis
    • glaucoma (Nitetime 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 (Nitetime only)

    When using this product,

    do not use more than directed.

    In addition, when using Nitetime:

    • 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

    Nitetime: 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

    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

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

  • Principal Display Panel

    Compare to the Active Ingredients in Vicks® DayQuil® and NyQuil® LiquiCaps®†

    NON-DROWSY DAYTIME / MULTI-SYMPTOM NITETIME

    COLD/FLU RELIEF LIQUID CAPS

    Acetaminophen - Pain Reliever-Fever Reducer / Acetaminophen - Pain Reliever-Fever Reducer

    Dextromethorphan HBr - Cough Suppressant / Dextromethorphan HBr - Cough Suppressant

    Phenylephrine HCl - Nasal Decongestant / Doxylamine Succinate - Antihistamine

    DAYTIME SOFTGELS / NITETIME SOFTGELS

    Alcohol Free

    Antihistamine Free

    When using Daytime and Nitetime products, carefully read the labeling to insure correct dosing

    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.

    DISTRIBUTED BY

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

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

  • Product Label

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

    Care One Daytime / Nitetime Cold Flu Relief

  • INGREDIENTS AND APPEARANCE
    DAYTIME NITETIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-491
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-491-481 in 1 CARTON; Type 0: Not a Combination Product08/14/201204/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 16 
    Part 24 BLISTER PACK 32 
    Part 1 of 2
    NITETIME 
    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
    ShapeCAPSULESize21mm
    FlavorImprint Code P30;94A;35A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/14/201204/01/2022
    Part 2 of 2
    DAYTIME 
    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
    ShapeCAPSULESize19mm
    FlavorImprint Code P19;95A;36A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/14/201204/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/14/201204/01/2022
    Labeler - Care One (American Sales Company) (809183973)
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