Label: EQUATE NITE TIME COLD FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid

  • 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 05/09

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

  • Active ingredient (in each 15 mL tablespoon)

    Acetaminophen 500 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

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  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

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  • 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
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  • Warnings

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

    • more than 4 doses in 24 hours, which is the maximum daily amount
    • 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 two 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.
    • 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. 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 recommended – see Liver warning
    • use dose cup
    • do not exceed 4 doses per 24 hours
    adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
    children 4 to under 12 years ask a doctor
    children under 4 years 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 TBSP contains: sodium 18 mg
    • store at 20°-25°C (68°-77°F)
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  • 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

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  • Questions or comments?

    1-888-287-1915

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  • Principal Display Panel

    See New Warnings Information

    Compare to NyQuil® Cold & Flu Active Ingredients

    NiteTime

    Cold & Flu

    Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

    Multi-Symptom Relief

    Aches, Fever - Acetaminophen

    Cough - Dextromethorphan HBr

    Sneezing, Runny Nose - Doxylamine Succinate

    Original Flavor

    10% Alcohol

    NiteTime Cold and Flu Label

    NiteTime Cold and Flu Label

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  • INGREDIENTS AND APPEARANCE
    EQUATE NITE TIME  COLD FLU RELIEF
    acetaminophen,dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-908
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 15 mL
    DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    ANHYDROUS CITRIC ACID  
    D&C YELLOW NO. 10  
    FD&C GREEN NO. 3  
    FD&C YELLOW NO. 6  
    HIGH FRUCTOSE CORN SYRUP  
    POLYETHYLENE GLYCOL  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM  
    SODIUM CITRATE  
    Product Characteristics
    Color GREEN (Bright) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-908-38 296 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/03/2005
    Labeler - Wal-Mart Stores Inc (051957769)
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