Label: NITE TIME- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate solution

  • NDC Code(s): 30142-459-30, 30142-459-34, 30142-459-38, 30142-459-40
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/14

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

  • Active ingredients (in each 30 mL dose cup)

    Acetaminophen 650 mg

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

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  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

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  • Uses

    temporarily relieves common cold/flu symptoms:

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

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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, lasts for more than 2 days, occurs with or is 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
    to make a child sleepy

    Ask a doctor before use if you have

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

    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.

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  • Directions

    take only as directed - see Liver warning
    use dose cup
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL (2 TBSP) every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

    when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
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  • Other information

    each 30 mL dose cup contains: sodium 39 mg
    store at 20-25°C (68-77°F)
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  • Inactive ingredients

    alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

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  • Questions or comments?

    1-800-632-6900

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  • Package/Label Principal Display Panel

    COMPARE TO the active ingredients of VICKS® NYQUIL® COLD & FLU

    See back panel

    Nite Time

    COLD & FLU

    Acetaminophen, Pain Reliever/Fever Reducer

    Dextromethorphan HBr, Cough Suppressant

    Doxylamine Succinate, Antihistamine

    Relieves:

    Aches, Fever, Sore Throat

    Sneezing, Runny Nose

    Cough

    ALCOHOL 10%

    Cherry Flavor

    12 FL OZ (354 mL)

    Nite Time Label
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  • INGREDIENTS AND APPEARANCE
    NITE TIME 
    acetaminophen, dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-459
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    ANHYDROUS CITRIC ACID  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    HIGH FRUCTOSE CORN SYRUP  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM  
    SODIUM CITRATE  
    Product Characteristics
    Color RED (Clear/Dark Red) Score     
    Shape Size
    Flavor CHERRY (Menthol Aroma) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-459-38 295 mL in 1 BOTTLE
    2 NDC:30142-459-30 177 mL in 1 BOTTLE
    3 NDC:30142-459-34 237 mL in 1 BOTTLE
    4 NDC:30142-459-40 354 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/26/2011
    Labeler - Kroger Company (006999528)
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