Label: NITE-TIME COLD/FLU MEDICINE- acetaminophen liquid

  • NDC Code(s): 76281-501-25, 76281-501-28
  • Packager: AptaPharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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

  • Active Ingredients

    Drug Facts

    Active ingredients (in each 30 mL dose cup)

    Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg 

  • Purpose

    Purpose

    Pain reliever/fever reducer   Cough suppressant   Antihistamine 

  • Keep Out Of Reach Of Children

    Keep out of reach of children.

  • Uses

    Uses temporarily relieves cold/flu symptoms:

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

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage
    may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is
    the maximum daily amount for this product ● with other drugs containing
    acetaminophen ● 3 or more alcoholic drinks everyday while using this product.

    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.

  • Ask A Doctor

    Ask a doctor before use if you have

    • a sodium restricted diet
    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland
  • Ask A Doctor Or Pharmacist

    Ask a doctor or pharmacist before use

    • if you are taking sedatives or tranquilizers
    • if you are taking the blood thinning drug warfarin
  • When Using This Product

    When using this product

    • do not use more than directed
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness
  • Stop Use And Ask A Doctor

    Stop use and ask a doctor if

    • redness or swelling is present
    • symptoms do not get better within 7 days or are accompanied by a fever
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts
  • Pregnant Or Breast-Feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • Overdose Warning

    Overdose warning: Taking more than the recommended dose can cause serious health problems. 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

    Directions

    • take only as recommended-see Overdose warnings
    • Use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours


    adults and children 12 years and over                     30 mL (2TBSP) every 6 hours
    children 4 to under 12 years                                   ask a doctor
    children under 4 years                                            do not use

    • If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

  • Other Information

    Other information

    • each 30 mL dose cup contains:
    • sodium 45 mg
    • store at room temperature
  • Inactive Ingredients

    Inactive ingredients: citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

  • Do Not Use

    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
  • Package Label - Night Time Cold & Flu Relief

    NDC 76281-501-28

    AP SAFE

    *COMPARE TO
    the active ingredients in
    VICKS® NYQUIL®

    Night Time

    Acetaminophen – Pain Reliever/Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Doxylamine Succinate – Antihistamine

    Multi-Symptom
    Cold & Flu Relief

    Original Flavor

    12 FL OZ (354 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

    Failure to follow these warnings could result in serious consequences

    *This product is not manufactured or distributed by Procter &
    Gamble, owner of the registered trademark Vicks® NyQuil®.

    Manufactured by: AptaPharma Inc.,
    1533 Union Ave., Pennsauken, NJ 08110

    12 OZ

    501-28 12oz Botl

    6 OZ

    501-25 6 OZ

    res

  • INGREDIENTS AND APPEARANCE
    NITE-TIME  COLD/FLU MEDICINE
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-501
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-501-28354 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    2NDC:76281-501-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/09/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-501)