Label: TOPCARE NITE TIME DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

  • NDC Code(s): 36800-143-73, 36800-580-72
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2024

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

View All Sections
  • Active ingredients (in each softgel) – Nitetime Cold & Flu

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • Active ingredients (in each softgel) – Daytime Cold & Flu

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purpose – Nitetime Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Purpose – Daytime Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses – Nitetime Cold & Flu

    temporarily relieves common cold/flu symptoms:

    •
    cough due to minor throat and bronchial irritation
    •
    minor aches and pains
    •
    sore throat
    •
    headache
    •
    runny nose and sneezing
    •
    fever
  • Uses – Daytime Cold & Flu

    temporarily relieves common cold/flu symptoms:

    •
    cough due to minor throat and bronchial irritation
    •
    minor aches and pains
    •
    sore throat
    •
    headache
    •
    nasal congestion
    •
    fever
  • Warnings

    Liver warning: This product contains 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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.
    •
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have – Nighttime Cold & Flu

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

    Ask a doctor before use if you have – Daytime Cold & Flu

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

    Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu

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

    Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu

    taking the blood thinning drug warfarin

    When using this product

    •
    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

    When using this product – Daytime Cold & Flu

    do not use more than directed

    Stop use and ask a doctor if – Nighttime Cold & Flu

    •
    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.

    Stop use and ask a doctor if – Daytime Cold & Flu

    •
    you get nervous, dizzy or sleepless
    •
    pain, nasal congestion 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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions – Nitetime Cold & Flu

    •
    take only as directed – see overdose warning
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    2 softgels with water every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Directions – Daytime Cold & Flu

    •
    take only as directed – see overdose warning
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    2 softgels with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients – Nitetime Cold & Flu

    D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Inactive ingredients – Daytime Cold & Flu

    edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel - Daytime

    SPECIAL VALUE! COMBINATION PACK

    Top Care® health

    COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS

    MULTI-SYMPTOM RELIEF

    Day Time Cold & Flu Relief

    PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN

    COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

    NASAL DECONGESTANT - PHENYLEPHRINE HCl

    • Headache, Fever, Sore Throat, Minor Aches & Pains

    • Nasal Congestion

    • Cough

    Alcohol Free

    Antihistamine Free

    Non-Drowsy

    actual size

    32 SOFTGELS

    Top Care® health

    COMPARE TO VICKS® NYQUIL® COLD & FLU ACTIVE INGREDIENTS

    MULTI-SYMPTOM RELIEF

    Nite Time Cold & Flu Relief

    PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN

    COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

    ANTIHISTAMINE - DOXYLAMINE SUCCINATE

    • Headache, Fever, Sore Throat, Minor Aches & Pains

    • Sneezing, Runny Nose

    • Cough

    Alcohol Free

    actual size

    16 SOFTGELS

    Daytime Nighttime Cold and Flu Relief Image 1
    Daytime Nighttime Cold and Flu Relief Image 2
  • INGREDIENTS AND APPEARANCE
    TOPCARE NITE TIME DAY TIME  COLD AND FLU
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-580
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-580-721 in 1 CARTON; Type 0: Not a Combination Product04/29/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 BLISTER PACK 16 
    Part 216 BLISTER PACK 32 
    Part 1 of 2
    TOPCARE NITE TIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
    Product Information
    Item Code (Source)NDC:36800-143
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorGREEN (clear) Scoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 056
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-143-738 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/02/2014
    Part 2 of 2
    TOPCARE DAY TIME 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code L994
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/28/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/29/2014
    Labeler - Topco Associates LLC (006935977)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!