ARAMARK PAIN-FREE EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Western First Aid Safety DBA Aramark

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acetaminophen ....Pain Reliever/Fever Reducer Aspirin (NSAID) ....Pain Reliever/Fever Reducer Caffeine ...............Adjuvent Uses: Temporarily Relieves minor aches and pains associated with: • backach • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • Do not use:    • with any other pain reliever/fever reducer    • for pain for more than 10 days or for fever for      more than 3 days unless directed by a doctor    • if you have ever had an allergic reaction to      any other pain reliever/fever reducer Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present

Authorization status:

OTC monograph not final

Summary of Product characteristics

ARAMARK PAIN-FREE EXTRA STRENGTH- ACETAMINOPHEN, ASPIRIN,
CAFFEINE TABLET
WESTERN FIRST AID SAFETY DBA ARAMARK
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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ARAMARK PAIN-FREE EXTRA STRENGTH
_DRUG FACTS_
EXTRA STRENGTH PAIN RELIEVER M560L
ACTIVE INGREDIENTS (IN EACH TABLET)
Acetaminophen 250 mg
Aspirin (NSAID) 250 mg
Caffeine 65 mg
Acetaminophen ....Pain Reliever/Fever Reducer
Aspirin (NSAID) ....Pain Reliever/Fever Reducer
Caffeine ...............Adjuvent
_USES:_
Temporarily Relieves minor aches and pains
associated with: • backach • headaches
• colds • toothache • minor arthritis pain
• muscular aches • menstrual cramps
WARNINGS:
• REYE’S SYNDROME: Children and teenagers should not
use this medicine for chicken pox or flu symptoms
before a doctor is consulted about Reye’s Syndrome,
a rare but serious illness reported to be associated
with aspirin.
• ALLERGY ALERT - Do not use:
• if you are allergic to aspirin or any other salicylate
• if you have ever had an allergic reaction to any
other pain reliever/fever reducer
• LIVER WARNING: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen
(Prescription or nonprescription)
• Ask a doctor or pharmacist before using with
other drugs if you are not sure.
• 3 or more alcoholic drinks every day while
using this product.
• STOMACH BLEEDING WARNING: This product contains
nonsteroidal anti-inflammatory drugs (NSAIDs),
which may cause 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 an NSAID (aspirin,
ibuprofen, naproxen, or others)
• take more or for a longer time than directed
• DO NOT USE:
• with