XL-3 DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.]

XL-3 DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.]
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NDC 76281-304-28, 76281-306-25
Set ID 94e02be4-b8a6-422a-8f66-e6a69e924b2c
Category HUMAN OTC DRUG LABEL
Packager AptaPharma Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 15 mL, 1 tablespoon)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCI 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough Suppressant
    Nasal decongestant

  • Uses

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

  • 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, lasts 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 products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than10 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Ask a doctor before use if you have

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

  • 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 (see
    overdose warning) • avoid alcoholic drinks

  • Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms get worse or last more than 5 days (children) or 7days (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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Overdose warning:

    Taking more than the recommended dose
    (overdose) may cause serious health problems including liver damage.
    In case of accidental overdose, get medical help or contact a Poison
    Control Center (1-800-222-1222) right away.
    Prompt medical attention is critical for adults as well as children even if
    you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions • take only as directed - see Overdose warning
    • use dose cup or tablespoon • do not exceed 4 doses per 24 hours
    • if taking Day Time during the day and Night Time at night, limit total to
    4 doses per 24 hours

    adults & children 12 years and over        30 mL (2 TBSP) every 4 hours

    children 6 to under 12 years                 15mL (1TBSP) every 4 hours

    children 4 to under 6 years                   ask a doctor

    children under 4 years                         do not use

  • Other information

    • Sodium content per tablespoon: 10mg
    • store at 20°-25°C (68°-77° F).

  • Inactive ingredients

     citric acid, FD & C Yellow No.6, flavor, glycerin,
    propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose.

  • Questions or Comments?

    Call weekdays from 9:30 AM to 4:30 PM EST
    1-877-798-5944

  • Principal Display Package

    XL-3 Day Time

    XL-3 Day Time 2

    XL-3*
    Day Time
    Non-Drowsy Cold/Flu relief

    COLD MEDICINE

    • Acetaminophen - Pain Reliever/Fever Reducer
    • Dextromethorphan HBr - Cough Suppressant
    • Phenylephrine HCI - Nasal Decongestant

    Fast Relief of:
    NASAL CONGESTION
    FEVER
    ACHES & PAINS
    SORE THROAT
    COUGH                       

    12 FL OZ (354 mL)    Orange Flavor

    XL-3*
    Day Time
    Non-Drowsy Cold/Flu relief

    COLD MEDICINE

    • Acetaminophen - Pain Reliever/Fever Reducer
    • Dextromethorphan HBr - Cough Suppressant
    • Phenylephrine HCI - Nasal Decongestant

    Fast Relief of:
    NASAL CONGESTION
    FEVER
    ACHES & PAINS
    SORE THROAT
    COUGH                  

    12 FL OZ (354 mL)          Orange Flavor

    XL-3* Day Time

    COLD MEDICINE

    DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    Drug Facts

    Active ingredients                                                                   Purpose
    (in each 15 mL, 1 tablespoon)
    Acetaminophen 325 mg ........................ Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg .........................Cough Suppressant
    Phenylephrine HCI 5 mg .................................Nasal decongestant

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

    → DRUG FACTS CONTINUED ON BACK →

    Distributed by:
    Midway Importing, Inc.
    1807 Brittmoore Road,
    Houston, TX 77043 1-800-531-3873
    Made in USA
                                        Peel
    LR-059 REV 03             back ►

    XL-3* Day Time

    COLD MEDICINE

    Drug Facts (continued)

    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, lasts 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 products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than10 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have • liver disease
    • heart disease • thyroid disease • diabetes • high blood pressure
    • trouble urinating due to enlarged prostate gland • cough accompanied by
    excessive phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. ►

    Drug Facts (continued)

    When using this product • do not use more than directed (see
    overdose warning) • avoid alcoholic drinks

    Stop use and ask a doctor if • you get nervous, dizzy or sleepless
    • symptoms get worse or last more than 5 days (children) or 7days (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: Taking more than the recommended dose
    (overdose) may cause serious health problems including liver damage.
    In case of accidental overdose, get medical help or contact a Poison
    Control Center (1-800-222-1222) right away.
    Prompt medical attention is critical for adults as well as children even if
    you do not notice any signs or symptoms.

    Directions • take only as directed - see Overdose warning
    • use dose cup or tablespoon • do not exceed 4 doses per 24 hours
    • if taking Day Time during the day and Night Time at night, limit total to
    4 doses per 24 hours
    ___________________________________________________________
    adults & children 12 years and over │ 30 mL (2 TBSP) every 4 hours
    ___________________________________________________________
    children 6 to under 12 years            │ 15mL (1TBSP) every 4 hours
    ___________________________________________________________
    children 4 to under 6 years              │ ask a doctor
    ___________________________________________________________
    children under 4 years                     │ do not use
    ___________________________________________________________
    Other information • Sodium content per tablespoon: 10mg
    • store at 20°-25°C (68°-77° F).

    Inactive ingredients citric acid, FD & C Yellow No.6, flavor, glycerin,
    propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose.

    Questions or Comments? Call weekdays from 9:30 AM to 4:30 PM EST
    1-877-798-5944


    XL-3*
    Day Time
    Non-Drowsy Cold/Flu relief

    COLD MEDICINE

    • Acetaminophen - Pain Reliever/Fever Reducer
    • Dextromethorphan HBr - Cough Suppressant
    • Phenylephrine HCI - Nasal Decongestant

    Fast Relief of:
    NASAL CONGESTION
    FEVER
    ACHES & PAINS
    SORE THROAT
    COUGH                       

     6 FL OZ (177 mL)                                           Orange Flavor

    XL-3 6_OZ

  • INGREDIENTS AND APPEARANCE
    XL-3 DAY TIME 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-304
    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) PHENYLEPHRINE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BEHENATE (UNII: H4W8BMK72F)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-304-28354 mL in 1 BOTTLE, PLASTIC; 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
    XL-3 DAY TIME 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-306
    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) PHENYLEPHRINE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BEHENATE (UNII: H4W8BMK72F)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-306-25177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-304, 76281-306)

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