Label: DAYTIME NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

  • NDC Code(s): 72476-850-48
  • Packager: Care One (Retail Business Services, LLC.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients for Daytime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Active ingredients for 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 congestion
      • 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 and sneezing
  • Warnings

    DAYTIME

    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 these products

    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.

    NIGHTTIME

    Liver warning: This product 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

    Alergy 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 following by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

    Do not use

    DAYTIME

    • 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.

    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 occurs 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 exceed recommended dosage

    NIGHTTIME

    • do not exceed recommended dosage
    • 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, and 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 headache that lasts.

    These could be a 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

    DAYTIME

    • 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
    • adults and children 12 years and over; take 2 softgels with water every 4 hours.
    • children under 12 years: do not use

    NIGHTTIME

    • 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
    • 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, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

    NIGHTTIME

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

  • 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® Cold & Flu LiquiCap®†

    DAYTIME

    MULTI-SYMPTOM

    COLD / FLU RELIEF

    Pain reliever/Fever Reducer - Acetaminophen

    Cough Suppressant - Dextromethorphan HBr

    Nasal Decongestant - Phenylephrine HCI

    Relieves Major cold & Flu Symptoms:

    Aches & Fever,Sore Throat, Coughing, Congestion

    SOFTGELS

    NIGHTTIME

    MULTI-SYMPTOM

    COLD / FLU RELIEF

    Pain Reliever/ Fever Reducer - Acetaminophen

    Cough Suppressant - Dextromethorphan HBr

    Antihistamine - Doxylamine succinate

    Relieves Cold & Flu Symptoms

    So You Can Rest

    SOFTGELS

    †This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil, NyQuil®, and 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 SHOW SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

    DISTRIBUTED BY

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

  • 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

    CAREONE Daytime Nighttime Multi Symptom Cold & Flu Relief

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-850
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-850-481 in 1 KIT; Type 0: Not a Combination Product09/30/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 116 BLISTER PACK 16 
    Part 232 BLISTER PACK 32 
    Part 1 of 2
    NIGHTTIME COLD FLU RELIEF 
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P30
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/30/2019
    Part 2 of 2
    DAYTIME COLD FLU RELIEF 
    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 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)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P19
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    132 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/30/2019
    Labeler - Care One (Retail Business Services, LLC.) (967989935)