Acetaminophen tablet, film coated, extended release

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • muscular aches
  • backache
  • minor pain of arthritis
  • toothache
  • premenstrual and menstrual cramps
  • headache
  • the common cold
  • temporarily reduces fever

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.

Directions

  • do not take more than directed (see overdose warning)
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 doctordo not use

    adults and children 12 years and over

    children under 12 years

    Other information

    • store at 20-25 C (68-77 F)
    • meets the requirements of USP Dissolution Test 2

    Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

    Questions or comments?

    1-800-632-6900

    Ingredients and appearance - Product information

    Acetaminophen tablet, film coated, extended release- Acetaminophen

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 30142-119
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 650 mgin 1

    Inactive Ingredients

    Ingredient Name Code
    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 glycol ( UNII: 3WJQ0SDW1A)
    Polysorbate 80 ( UNII: 6OZP39ZG8H)
    Povidone ( UNII: FZ989GH94E)
    Stearic acid ( UNII: 4ELV7Z65AP)
    Titanium dioxide ( UNII: 15FIX9V2JP)

    Product Characteristics

    Color WHITE Size 19 mm
    Shape OVAL Score 1
    Imprint Code L544

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    ANDA ANDA075077 USA

    Labeler - Kroger Company( 006999528)

    Package/label principal display panel

    COMPARE TO the active ingredient of TYLENOL ®8HR See inside panel

    OUR PHARMACIST RECOMMENDED

    8 Hour Pain Relief

    actual size

    Acetaminophen Extended-Release Tablets, 650 mg

    Pain Reliever/Fever Reducer

    For up to 8 Hours Relief of Minor Muscle Aches & Pain

    100 CAPLETS** 650 mg EACH

    **capsule-shaped tablets

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING