Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 21130-484-02, 21130-484-62, 21130-484-71, 21130-484-76, view more
    21130-484-78, 21130-484-85, 21130-484-90
  • Packager: Safeway
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/fever reducer

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  • 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
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  • Directions

    do not take more than directed (see Liver warning)

    adults and children 12 years and over

    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

    children under 12 years

    ask a doctor

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  • Other information

    store at 20-25°C (68-77°F)
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  • Inactive ingredients

    carnauba wax*, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

    *may contain one or more of these ingredients

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  • Questions or comments?

    1-888-SAFEWAY

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  • Principal Display Panel

    Extra Strength

    Compare to Extra Strength Tylenol® Caplets active ingredient

    Aspirin-Free

    Pain Relief

    Acetaminophen Caplets, 500 mg

    Pain Reliever

    Fever Reducer

    For Adults

    ACTUAL SIZE

    250 CAPLETS

    Safeway Inc. Pain Relief
    Safeway Inc. Pain Relief
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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-484
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE (caplet) Size 16mm
    Flavor Imprint Code L484
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-484-62 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:21130-484-78 1 in 1 CARTON
    2 100 in 1 BOTTLE
    3 NDC:21130-484-85 1 in 1 CARTON
    3 250 in 1 BOTTLE
    4 NDC:21130-484-90 500 in 1 BOTTLE
    5 NDC:21130-484-76 1 in 1 CARTON
    5 120 in 1 BOTTLE
    6 NDC:21130-484-71 1 in 1 CARTON
    6 50 in 1 BOTTLE
    7 NDC:21130-484-02 550 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 07/06/2000
    Labeler - Safeway (009137209)
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