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Headache Relief (acetaminophen 250 mg aspirin 250 mg caffeine 65 mg) Dailymed

  1. Human OTC
  2. Archived
  3. GREENBRIER INTERNATIONAL, INC.

Generic: acetaminophen, aspirin and caffeine

Headache Relief tablet, film coated - (acetaminophen 250 mg aspirin 250 mg caffeine 65 mg) image
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IMPRINT: 44 159     SHAPE: round
    COLOR: white

All Imprints

acetaminophen 250 mgaspirin 250 mgcaffeine 65 mg - 44 159 round white

pain reliever added strength - acetaminophen 250 mg / aspirin 250 mg / caffeine 65 mg oral tablet - 44 159 round white

  1. FDA Adverse Reactions

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Active Ingredients (in Each Tablet)


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

*nonsteroidal anti-inflammatory drug

Purpose


Pain relieverPain relieverPain reliever aid

Uses

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

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 nausea 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)

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • with other drugs containing acetaminophen
  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 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:
  • take more or for a longer time than directed
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product

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, occasionally, rapid heartbeat.

Do not use

  • if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
  • 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 asthma
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • stomach bleeding warning applies to you
  • you have liver 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
  • painful area is red or swollen
  • fever gets worse or lasts for more than 3 days

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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: ask a doctor

Other Information

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

Inactive Ingredients


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

Questions Or Comments?


1-800-426-9391 

Principal Display Panel


ASSURED™

COMPARE TO ACTIVE INGREDIENTS OF EXCEDRIN® EXTRA STRENGTH†

EXTRA STRENGTH Headache Relief • Acetaminophen, Aspirin (NSAID) & Caffeine Pain Reliever / Pain reliever aid

Actual Size

24 tablets

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

†This product is not manufactured or distributed byNovartis AG, owner of the registered trademarkExcedrin® Extra Strength.  50844     REV0117D15908ITEM# 166326Distributed by: Greenbrier International, Inc. Chesapeake, VA 23320 USA
Assured 44-159B

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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