Label: EXTRA STRENGTH ASPIRIN FREE PAIN RELIEF- acetaminophen capsule 

  • 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 10/12

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

  • Active ingredients (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:
      • headache
      • the common cold
      • backache
      • minor pains of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever 
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  • Warnings

    Liver warnings: This product contains acetaminophen.  Severe liver damage may occur if you take:

    • more than 8 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 

    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. 

    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 befure use. 

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

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  • Directions

    • do not take more than directed (see overdose warning)
    • adults and children 12 years and over
      • take 2 caplets every 4 to 6 hours while symptoms last
      • swallow whole - do not crush, chew or dissolve
      • do not take more than 8 caplets in 24 hours
      • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: doi not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. 
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  • Other information

    • store at 25ºC (77ºC); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    corn starch, flavor, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

    *may contain this ingredient 

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  • Questions or comments?

    1-800-426-9391

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  • Principal display panel

    NDC 21130-445-15
    Compare to Tylenol® Extra Strength Cool Caplets active ingredient†

    Extra Strength
    Aspirin Free Pain Relief
    Acetaminophen
    , 500 mg
    • Cool Caplets
    • Pain Reliever
    • Fever Reducer

    50 CAPLETS, 500 mg EACH

    SAFEWAY

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Tylenol® Extra Strength Cool Caplets.

    50844        REV0112A44515

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Safeway 44-445

    Safeway 44-445

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ASPIRIN FREE PAIN RELIEF 
    acetaminophen capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-445
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    SUCRALOSE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code 44;445
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-445-15 1 in 1 CARTON
    1 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/10/2005
    Labeler - Safeway (009137209)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(21130-445)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(21130-445)
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