Label: 8 HOUR PAIN RELIEF- acetaminophen tablet, film coated, extended release

  • NDC Code(s): 42507-217-71, 42507-217-78
  • Packager: HyVee Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 02/15

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  • Active ingredient (in each caplet)

    Acetaminophen 650 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves minor aches and pains due to:
    muscular aches
    backache
    headache
    minor pain of arthritis
    temporarily reduces fever
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  • Warnings

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

    more than 6 caplets 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

    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.

    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 allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have

    liver disease

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    pain gets worse or lasts more than 10 days
    fever gets worse or lasts more than 3 days
    new symptoms occur
    redness or swelling is present

    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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    do not take more than directed (see overdose warning)

    adults and children 12 years and over

    take 2 caplets every 8 hours with water
    swallow whole; do not crush, chew, split or dissolve
    do not take more than 6 caplets in 24 hours
    do not use for more than 10 days unless directed by a doctor

    children under 12 years

    do not use
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  • Other information

    store at 20-25 °C (68-77 °F). Avoid excessive heat 40 °C (104 °F).
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    See New Warning

    COMPARE TO the Active Ingredient of Tylenol® 8HR

    8 Hour Pain Relief

    Acetaminophen Extended-Release Tablets, 650 mg

    Pain Reliever / Fever Reducer

    For Up to 8 Hour Relief of Minor Muscle Aches and Pain

    Headache

    Backache

    Minor Pain of Arthritis

    50 CAPLETS*

    650 mg EACH

    *Capsule-Shaped Tablets

    8 Hour Pain Relief Carton Image 1
    8 Hour Pain Relief Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    8 HOUR PAIN RELIEF 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-217
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code L217
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-217-71 1 in 1 CARTON
    1 50 in 1 BOTTLE
    2 NDC:42507-217-78 1 in 1 CARTON
    2 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075077 09/23/2005
    Labeler - HyVee Inc (006925671)
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