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Maximum Strength Flu HBP (Ilex Consumer Products Group, LLC)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BLISTER PACK in 1 CARTON (76000-461-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK Label Information

Complete Maximum Strength Flu HBP Information

  • Active ingredients (in each tablet)

    Acetaminophen 500 mg
    Chlorpheniramine maleate 2 mg
    Dextromethorphan HBr 15 mg


  • Purpose

    Pain reliever/fever reducer
    Antihistamine
    Cough suppressant


  • Uses

    • temporarily relieves:
      • minor aches and pains
      • headache
      • cough
      • sneezing
      • runny nose
    • temporarily reduces fever

  • Warnings

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

    • more than 8 tablets 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

    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.

    Ask a doctor before use if you have
    • trouble urinating due to an enlarged prostate gland
    • liver disease
    • cough that occurs with too much phlegm (mucus)
    • glaucoma
    • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

    When using this product
    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if
    • pain or cough gets worse or lasts more than 7 days
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • 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 liver damage. 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

    • do not take more than directed (see overdose warning)
    • adults and children 12 years and over: 2 tablets every 6 hours while symptoms persist. Do not take more than 8 tablets in 24 hours.
    • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • protect from excessive moisture 
    • see end flap for expiration date and lot number

  • Inactive ingredients

    corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide


  • Questions or comments?

    1-855-STJ-6381


  • Principal Display Panel

    NDC 76000-461-08

    ST. JOSEPH®

    DECONGESTANT-FREE

    HBP

    COLD RELIEF for people with
    High Blood Pressure
    MAXIMUM
    STRENGTH
    FLU
    Pain Reliever/Fever Reducer - Acetaminophen
    Antihistamine - Chlorpheniramine maleate
    Cough Suppressant - Dextromethorphan HBr

    Relieves:
    Body Aches, Pains and Headache
    Fever Cough
    Runny Nose

    Actual Size

    24 Tablets

    REV0512A46108

    Blister opening instructions:
    Fold along perforations; peel back at arrows; push product through foil.

    Distributed by:
    St. Josephs Health Products, LLC
    Baltimore, MD 21201
    1-855-STJ-6381
    www.stjosephaspirin.com

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    St. Joseph 44-461

    St. Jospeh 44-461


  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH FLU HBP 
    acetaminophen, dextromethorphan hbr, chlorpheniramine maleate tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76000-461
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color RED Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code 44;461
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76000-461-08 2 in 1 CARTON 06/01/2005 07/08/2019
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 06/01/2005 07/08/2019
    Labeler - Bedrock Brands, LLC (829056162)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(76000-461)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(76000-461)