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

  • NDC Code(s): 36800-335-40, 36800-522-40, 36800-567-02
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2024

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  • Nighttime Cold & Flu Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    •
    cough due to minor throat and bronchial irritation
    •
    sore throat
    •
    headache
    •
    minor aches and pains
    •
    fever
    •
    runny nose and sneezing
  • 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, persists 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

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

    Ask a doctor or pharmacist before use if you are

    •
    taking sedatives or tranquilizers
    •
    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

    Stop use and ask a doctor if

    •
    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.

    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

    •
    take only as directed – see Overdose warning
    •
    only use the dose cup provided
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    each 30 mL contains: sodium 38 mg
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

    1-888-423-0139

  • Daytime Cold & FluActive ingredients (in each 15 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

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

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    •
    adult takes more than 4,000 mg of acetaminophen in 24 hours
    •
    child takes more than 5 doses in 24 hours
    •
    taken with other drugs containing acetaminophen
    •
    adult has 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

    •
    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

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

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    •
    you get nervous, dizzy or sleepless
    •
    pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    •
    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

    •
    take only as directed – see Overdose warning
    •
    only use the dose cup provided
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 4 hrs

    children 6 to under 12 yrs

    15 mL every 4 hrs

    children 4 to under 6 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    each 15 mL contains: sodium 7 mg
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    SPECIAL VALUE! COMBINATION PACK

    TopCare® health

    COMPARE TO VICKS® DAYQUIL® 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

    12 FL OZ (355 mL)

    ORIGINAL FLAVOR

    TopCare® health

    COMPARE TO VICKS® NYQUIL® ACTIVE INGREDIENTS

    MULTI-SYMPTOM RELIEF

    Nite Time Cold & Flu Relief

    PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN

    COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

    ANTIHISTAMINE - DOXYLAMINE SUCCINANATE

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

    • Sneezing, Runny Nose

    • Cough

    ALCOHOL 10%

    12 FL OZ (355 mL)

    ORIGINAL FLAVOR

    daytime nitetime cold and flu relief-image 1
    daytime nitetime cold and flu relief-image 2
  • INGREDIENTS AND APPEARANCE
    TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-567
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-567-021 in 1 CARTON; Type 0: Not a Combination Product08/07/2012
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 355 mL
    Part 21 BOTTLE 355 mL
    Part 1 of 2
    TOPCARE NITE TIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Item Code (Source)NDC:36800-335
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorGREEN (clear, bright green) Score    
    ShapeSize
    FlavorFRUIT (anise / cooling menthol aroma) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-335-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/18/2011
    Part 2 of 2
    TOPCARE DAY TIME COLD AND FLU RELIEF  MULTI SYMPTOM RELIEF
    acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
    Product Information
    Item Code (Source)NDC:36800-522
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorORANGE (clear) Score    
    ShapeSize
    FlavorMENTHOL (with fruit) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-522-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/17/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/07/2012
    Labeler - Topco Associates LLC (006935977)
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