NITE-TIME COLD/FLU MEDICINE CHERRY (ACETAMINOPHEN) LIQUID [APTAPHARMA INC.]

NITE-TIME COLD/FLU MEDICINE CHERRY (ACETAMINOPHEN) LIQUID [APTAPHARMA INC.]
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NDC 76281-502-28
Set ID 87c2b823-ed88-44f3-8f6a-df30430b40f3
Category HUMAN OTC DRUG LABEL
Packager AptaPharma Inc.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • 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

    Failure to follow these warnings could result in serious consequences

    Warnings

    Liver warnings:

     This product contains acetaminophen. Sever 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 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 alcohol 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 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, or headache that lasts

    These could be signs of a serious condition.

  • Pregnancy 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

    • take only as recommended-see Overdose warning
    • Use dose cup or tablespoon (TBSP)
    • 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
    ____________________________________________________________________

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

  • Other Information

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

    Inactive ingredients: citric acid, FD and C Blue No. 1, FD and C Red No. 40, 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 afet 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 Multi-Symptom Cherry Flavor

    NDC 76281-502-28

    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

    Cherry Flavor

    12 FL OZ (354 mL)

    DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    Drug Facts

    Active ingredients (in each 30 mL dose cup) Purpose
    Acetaminophen 650 mg…………………………………Pain reliever/fever reducer
    Dextromethorphan HBr 30 mg………………………….………Cough suppressant
    Doxylamine Succinate 12.5 mg……………………………..…………Antihistamine

    Uses temporarily relieves cold/flu symptoms: ■ sore throat ■ headache
    ■ minor aches and pains ■ fever ■ runny nose and sneezing
    ■ cough due to minor throat and bronchial irritation

    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 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 ■ for more than 10 days for pain unless directed by
    a doctor ■ for more than 3 days for fever unless directed by a doctor. ■ 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 a pharmacist before taking this product ■ to make a child sleepy

    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 prostrate gland

    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 ■ do not use more than directed ■ avoid alcoholic drinks
    ■ excitability may occur, especially in children ■ marked drowsiness may occur ►

    Drug Facts (continued)

    ■ be careful when driving a motor vehicle or operating machinery
    ■ alcohol, sedatives, and tranquilizers may increase drowsiness

    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, 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: Taking more than the recommended dose (overdose) may
    cause liver damage. In case of accidental overdose, get medical help or contact
    a Poison Control Center right away. Prompt medical attention is critical for
    adults as well as for children even if you do not notice any signs or symptoms.

    b ■ take only as recommended-see Overdose warning
    ■ Use dose cup or tablespoon (TBSP) ■ do not exceed 4 doses per 24 hours
    ■ If taking Night Time at night and Day Time during the day, limit total to 4
    doses per 24 hours.

    adults & 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

    Other information ■ each 30 mL dose cup Made in USA
    contains: sodium 45 mg ■ store at room temperature AP-LR-09

    Inactive ingredients citric acid, FD&C Blue No.1,
    FD&C Red No. 40, flavor, glycerin, polyethylene glycol,
    propylene glycol, purified water, saccharin sodium, sodium
    benzoate, sodium citrate, sucrose

    Questions? Call weekdays 1-877-798-5944

    *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

    cherry

    6 oz

    502 6oz label

    res

  • INGREDIENTS AND APPEARANCE
    NITE-TIME  COLD/FLU MEDICINE CHERRY
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-502
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (CHERRY FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-502-28354 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    2NDC:76281-502-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-502) , pack(76281-502) , label(76281-502)

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