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Headache Relief Dailymed

  1. Human OTC
  2. Platelet Aggregation Inhibitor
  3. Safeway, Inc.

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 - image

  1. FDA Adverse Reactions

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Active Ingredients (in Each Geltab)


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 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 4,000 mg of acetaminophen in 24 hours
  • 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 history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic

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.
  • 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
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur

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 at 20 weeks or later in 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 (1-800-222-1222) 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 geltabs every 6 hours; do not take more than 8 geltabs in 24 hours
  • children under 12 years: do not use unless directed by a doctor

Other Information

  • store between 20Âş-25ÂşC (68Âş-77ÂşF)

Inactive Ingredients


black printing ink, corn starch, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hydroxypropyl cellulose, hydroxypropyl cellulose-low substituted, hypromellose, iron oxide black, maltitol, povidone, purified water, stearic acid, talc, titanium dioxide

Questions Or Comments?


Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel


COMPARE TO Excedrin® Extra Strength active ingredients†

Extra Strength

Headache Relief

ACETAMINOPHEN 250 mg

ASPIRIN (NSAID) 250 mg

CAFFEINE 65 mg

Pain Reliever/Pain Reliever Aid

GELTABS

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Excedrin® Extra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

Package Label Green

SIGNATURE CARE Extra Strength Headache Relief

Package Label

SIGNATURE CARE 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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