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acetaminophen 500 mg caffeine 65 mg - 44 428 oval red

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

acetaminophen 500 mgcaffeine 65 mg - 44 428 oval red

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Active Ingredients (in Each Caplet)


Acetaminophen 500 mgCaffeine 65 mg

Purpose


Pain relieverPain reliever aid

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 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

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 are allergic to acetaminophen
  • 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


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 appear
  • symptoms do not get better or worsen
  • painful area is red and swollen
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts 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.


Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 (see overdose warning)
  • 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

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


QUALITY PLUS

NDC 50844-428-08 

*Compare to the active ingredients in Excedrin® Tension Headache

Aspirin Free

Tension Headache ReliefAcetaminophen & Caffeine Pain Reliever/Pain Reliever Aid

24 Coated Caplets

Actual Size

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Tension Headache.

50844    REV0113B42808

Distributed by LNK INTERNATIONAL, INC. 60 Arkay DriveHauppauge, NY 11788USA

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