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

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). Avoid excessive heat 40 C (104 F).

    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?

    1-800-719-9260

    Ingredients and appearance - Product information

    Acetaminophen tablet, film coated, extended release- Acetaminophen

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11822-0631
    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)
    Microcrystalline cellulose ( 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 CAPSULE Score 1
    Imprint Code L544

    Marketing Information

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

    Labeler - Rite Aid Corporation( 014578892)

    Package/label principal display panel

    Push & Turn Cap

    Compare to the active ingredient of Tylenol® 8HR

    8 hour pain relief

    acetaminophen

    extended-release tablets 650 mg

    ACTUAL SIZE

    pain reliever fever reducer

    for up to 8 hour relief of minor muscle aches & pain

    50 CAPLETS 650 mg EACH

    capsule-shaped tablets