Pain relief tablet, film coated

Active ingredient (in each tablet)

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. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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

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.

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 Liver warning)
take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets 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 20-25C (68-77F)

    Inactive ingredients

    carrageenan*, corn starch*, croscarmellose sodium*, FD&C red #40 aluminum lake, microcrystalline cellulose*, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide *may contain one or more of these ingredients

    Questions or comments?

    1-800-719-9260

    Ingredients and appearance - Product information

    Pain relief tablet, film coated- Acetaminophen

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 42507-200
    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
    Carrageenan ( UNII: 5C69YCD2YJ)
    Starch, corn ( UNII: O8232NY3SJ)
    Croscarmellose sodium ( UNII: M28OL1HH48)
    Cellulose, microcrystalline ( UNII: OP1R32D61U)
    Polyethylene glycol ( UNII: 3WJQ0SDW1A)
    Polyvinyl alcohol ( UNII: 532B59J990)
    Povidone ( UNII: FZ989GH94E)
    Stearic acid ( UNII: 4ELV7Z65AP)
    Sucralose ( UNII: 96K6UQ3ZD4)
    Talc ( UNII: 7SEV7J4R1U)
    Titanium dioxide ( UNII: 15FIX9V2JP)

    Product Characteristics

    Color RED Size 11 mm
    Shape ROUND (convex) Score 1
    Imprint Code L227

    Marketing Information

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

    Labeler - HyVee Inc( 006925671)

    Principal display panel

    Compare to the Active Ingredient of Extra Strength Tylenol®

    Pain Relief

    Extra Strength

    Pain Reliever/Fever Reducer

    Acetaminophen

    Contains No Aspirin

    50 Tablets 500 mg EACH

    For Adults

    Sweet Coated

    Easy Tabs

    ACTUAL SIZE