Leader acetaminophen capsule, coated

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

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.

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 have ever had an allergic reaction to this product or any of its ingredients

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 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

    adults and children 12 years and over

    children under

    12 years

    ask a doctor

    Other information

    • store at 20-25 C (68-77 F)

    Inactive ingredients

    croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid

    Questions or comments?

    1-800-719-9260

    Ingredients and appearance - Product information

    Leader acetaminophen capsule, coated- Acetaminophen

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70000-0200
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1

    Inactive Ingredients

    Ingredient Name Code
    Croscarmellose sodium ( UNII: M28OL1HH48)
    Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
    Hypromellose, unspecified ( UNII: 3NXW29V3WO)
    Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
    Polysorbate 80 ( UNII: 6OZP39ZG8H)
    Povidone, unspecified ( UNII: FZ989GH94E)
    Stearic acid ( UNII: 4ELV7Z65AP)
    Fd&c red no. 40 ( UNII: WZB9127XOA)
    Fd&c yellow no. 6 ( UNII: H77VEI93A8)

    Product Characteristics

    Color RED Size 18 mm
    Shape CAPSULE Score 1
    Imprint Code 3S0

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    OTC monograph not final part343 USA

    Labeler - Cardinal Health( 097537435)

    Package/label principal display panel

    Extra Strength

    Acetaminophen Caplets, 500 mg

    Pain Reliever / Fever Reducer

    FOR ADULTS

    Rapid Release

    COMPARE TO TYLENOL® EXTRA STRENGTH

    active ingredient

    100% Money Back Guarantee

    225 CAPLETS