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Tension Headache (acetaminophen 500 mg caffeine 65 mg) Dailymed

  1. Human OTC
  2. Central Nervous System Stimulant
  3. Cardinal Health 110, LLC. DBA Leader

Generic: acetaminophen, caffeine is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Apnea Fatigue

Tension Headache tablet, film coated - (acetaminophen 500 mg caffeine 65 mg) image
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IMPRINT: 44 428     SHAPE: oval
    COLOR: red

All Imprints

acetaminophen 500 mgcaffeine 65 mg - 44 428 oval red

acetaminophen 500 mg / caffeine 65 mg oral tablet - 44 428 oval red

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 500 mg(formulated with 65 mg caffeine)

Purpose


Pain reliever

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches 

Warnings


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

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

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

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 heart beat.

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. 
  • if you are allergic to acetaminophen

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

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

These could be signs of a serious condition. 

If pregnant or breast-feeding,


ask a health professional before use.

Keep out of reach of children.


In case of accidental overdose, get medical help or contact a Poison Control Center 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 take more than directed
  • adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets 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, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Questions Or Comments?


1-800-426-9391

Principal Display Panel


LEADERâ„¢

NDC 70000-0159-2

Tension Headache Acetaminophen, 500 mg Caffeine, 65 mg Pain reliever

Aspirin-Free

COMPARE TO EXCEDRIN® TENSION HEADACHE active ingredients*

100% Money Back Guarantee

100 CAPLETS

Actual Size

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

*This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark Excedrin® Tension Headache.

50844    REV1119B42812

CardinalHealth™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 

©2021 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

√ All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied.
Leader 44-428

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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