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

  1. Human OTC
  2. Platelet Aggregation Inhibitor
  3. The Kroger Co.

Generic: acetaminophen, aspirin, caffeine is used for the treatment of Arthritis, Rheumatoid Blood Coagulation Disorders Blood Platelet Disorders Cerebral Infarction Ischemic Attack, Transient Chickenpox Child, Preschool Fever Gout Hematemesis Hemorrhagic Disorders Infant Inflammation Melena Myocardial Infarction Nasal Polyps Osteoarthritis Pain Pre-Eclampsia Pregnancy Trimester, Third Rheumatic Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Apnea Fatigue

Headache Relief tablet - (acetaminophen 250 mg aspirin 250 mg caffeine 65 mg) image
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IMPRINT: TCL370     SHAPE: capsule
    COLOR: white

All Imprints

acetaminophen 250 mgaspirin 250 mgcaffeine 65 mg - tcl370 capsule white

acetaminophen 250 mg aspirin 250 mg caffeine 65 mg - tcl370 oval white

extra pain relief - acetaminophen 250 mg / aspirin 250 mg / caffeine 65 mg oral tablet - tcl370 oval white

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes


Pain reliever

Pain reliever

Pain reliever aid

Uses

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

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 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

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
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • 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
  • 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, 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 adoctor before use if

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have asthma
  • you are taking a diuretic
  • 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 doctor if

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

These could be signs of a serious condition

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.

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 caplets every 6 hours; do not take more than 8 caplets in 24 hours
  • children under 12 years: do not use unless directed by a doctor

Other Information

  • store between 20º-25ºC (68º-77ºF)

Inactive Ingredients


carnauba wax,  colloidal silicon dioxide, corn starch, hypromellose, microcrystalline cellulose, mineral oil, povidone, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?


Call 1-800-632-6900

Principal Display Panel


COMPARE TO the active ingredients in EXCEDRIN® EXTRA STRENGTH †See back panel

Extra Strength

Headache Relief

Acetaminophen 250 mg - Pain Reliever

Aspirin (NSAID) 250 mg - Pain Reliever

Caffeine 65 mg - Pain Reliever Aid

CAPLETS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.com

Package Label

KROGER Extra Strength Headache Relief

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."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"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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