XL-3 XTREME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [APTAPHARMA INC.]

XL-3 XTREME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [APTAPHARMA INC.]
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NDC 76281-305-28, 76281-307-25
Set ID dff79e0b-edf0-4dd3-a722-fd9beecd6293
Category HUMAN OTC DRUG LABEL
Packager AptaPharma Inc.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    (in each 30 mL dose cup)
    Acetaminophen 650 mgr
    Dextromethorphan HBr 30 mg
    Doxylamine Succinate 12.5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine

  • Use

    temporarily relieves cold/flu symptoms: • sore throat
    headache • minor aches and pain • 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 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.
    • 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 prostate 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 • 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

    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 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 contains: sodium 45 mg
    • store at 20°-25°C (68°-77° F).

  • 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

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

  • XL-3 Xtreme Night Time Cold and Cough

    XL-3 Night Time Xtreme

    XL-3 Xtreme 2

    XL-3* Xtreme
    Cherry Flavor
    Night Time

    Multi-Symptom Cold/Flu relief

    Cold and Cough
    Acetaminophen - Pain Reliever/Fever Reducer
    • Dextromethorphan HBr - Cough Suppressant
    • Doxylamine succinate - Antihistamine

    Fast Relief of:
    SNEEZING & RUNNY NOSE
    FEVER
    ACHES & PAINS
    COUGH
    SORE THROAT

    12 FL OZ (354 mL)

    XL-3* Xtreme
    Cherry Flavor
    Night Time

    Multi-Symptom Cold/Flu relief

    Cold and Cough
    Acetaminophen - Pain Reliever/Fever Reducer
    • Dextromethorphan HBr - Cough Suppressant
    • Doxylamine succinate - Antihistamine

    Fast Relief of:
    SNEEZING & RUNNY NOSE
    FEVER
    ACHES & PAINS
    COUGH
    SORE THROAT

    12 FL OZ (354 mL)

    XL-3* Xtreme

    Cold and Cough

    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 30 mL dose cup)
    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 pain • fever • runny nose and
    sneezing • cough due to minor throat and bronchial irritation

    → 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-060 REV 03                          back ►

    XL-3* Xtreme

    Cold and Cough

    Drug Facts (continued)

    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 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.
    • 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 prostate gland.

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

    Drug Facts (continued)

    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 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 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 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 contains: sodium 45 mg
    • store at 20°-25°C (68°-77° F).

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

    XL-3 NighTime 6_OZ

    XL-3* Xtreme
    Cherry Flavor
    Night Time

    Multi-Symptom Cold/Flu relief

    Cold and Cough
    • Acetaminophen - Pain Reliever/Fever Reducer
    • Dextromethorphan HBr - Cough Suppressant
    • Doxylamine succinate - Antihistamine

    Fast Relief of:
    SNEEZING & RUNNY NOSE
    FEVER
    ACHES & PAINS
    COUGH
    SORE THROAT

    6 FL OZ (177 mL)

  • INGREDIENTS AND APPEARANCE
    XL-3 XTREME 
    acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-305
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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:76281-305-28354 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
    XL-3 XTREME 
    acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-307
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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:76281-307-25177 mL in 1 BOTTLE; 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(76281-305, 76281-307)

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