Label: ADDED STRENGTH PAIN RELIEVER- acetaminophen, aspirin and caffeine tablet, film coated 

  • Label RSS
  • NDC Code(s): 21130-159-06, 21130-159-08, 21130-159-12
  • 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 tablet)

    Acetaminophen 250 mg
    Aspiring 250 mg (NSAID)*
    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • a cold
      • arthritis
      • muscular aches
      • sinusitis
      • toothache
      • premenstrual and menstrual cramps
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  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with naussea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

    • hives
    • facial swelling
    • shock
    • asthma (wheezing)

    Liver warning: This product contains acetaminophen. Severe lliver damage may occur if you take:

    • more than 8 tablets 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

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • hae had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs [aspiring, ibuprofen, naproxen or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionaly, rapid heartbeat.

    Do not use

    • if you ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
    • with any other drug containing acetaminophen (prescription or non prescription). 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
    • stomach bleeding warning appies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis or kidney disease

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug or are under a doctor's care for any serious condition

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away.
    • any new symptoms appear
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • painful area is red or swollen

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    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 use more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over
      • take 2 tablets every 6 hours
      • do not take more than 8 tablets in 24 hours
    • children under 12 years: do not use unless directed by a doctor
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  • Other information

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

    corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

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  • Principal Display Panel

    NDC 21130-159-06

    Compare to Excedrin® Extra Strength Tablets active ingredients†

    Value Size

    Added Strength
    Pain Reliever

    Acetaminophen 250 mg,
    Aspiring 250 mg (NSAID), Caffeine 65 mg

    •Pain Reliever
    •Pain Reliever Aid
    •Headache Relief

    200 COATED TABLETS

    SAFEWAY

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

    †This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributors of the registered trademark Excedrin® Extra Strength.

    DISTRIBUTED BY SAFEWAY INC.
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK
    1-888-SAFEWAY / www.safeway.com

    Safeway 44-159B

    Safeway 44-159B

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  • INGREDIENTS AND APPEARANCE
    ADDED STRENGTH PAIN RELIEVER 
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-159
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
    ASPIRIN (ASPIRIN) ASPIRIN 250 mg
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSPOVIDONE  
    HYPROMELLOSES  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    PROPYLENE GLYCOL  
    SODIUM LAURYL SULFATE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code 44;159
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-159-06 1 in 1 CARTON
    1 200 in 1 BOTTLE
    2 NDC:21130-159-08 1 in 1 CARTON
    2 24 in 1 BOTTLE, PLASTIC
    3 NDC:21130-159-12 1 in 1 CARTON
    3 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 11/17/1992
    Labeler - Safeway (009137209)
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