Acetaminophen, Aspirin (NSAID) and Caffeine
Drug Labeling and Warnings
Drug Details [pdf]
EXTRA PAIN RELIEF- acetaminophen, aspirin and caffeine tablet, film coated
AvPAK
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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Acetaminophen, Aspirin (NSAID) and Caffeine
ACTIVE INGREDIENTS
ACETAMINOPHEN 250 MG
ASPIRIN 250 MG (nsaid*)
CAFFEINE 65 MG
* NONSTEROIDAL ANIT-INFLAMMATORY DRUG
INACTIVE INGREDIENTS
Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Povidone, Pregelatinized Starch, Sodium Starch Gylolate, Stearic Acid, Titanium Dioxide
DIRECTIOINS
DO NOT USE MORE THAN DIRECTED - DRINK A FULL GLASS OF WATER WITH EACH DOSE - ADULTS AND CHILDREN 12 YEARS AND OVER TAKE 2 TABLETS EVERY 6 HOURS, NOT MORE THAN 8 TABLETS IN 24 HOURS .
USES
TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps
Do not use if you have ever had an allergic reaction to acetaminophe, 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.
WARNINGS
REYE'S SYNDROME:
Children and teenages 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 eary sign of Reye's syndrome, a rare but serious illnes.
ALLERY ALERT
Aspirin may cause a severe allergic reaction which may include:
hives
facial swelling
asthma (sheezing)
shock
LIVER WARNING:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maximum daily amount;
with other drugs containing acetaminophen;
3 or more alcoholic drinks every day while usng 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 (anticogulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,naproxen, or others)
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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.
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 sighs or symptoms
If Pregnant or breast-feeding ask a helth 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 becausde it may cause prombles inthe unborn child or complications during delivery.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 50268-053-15
EXTRA PAIN RELIEF
Acetaminophen, Aspirin (NSAID) and Caffeine
EXTRA STREGTH
50 Tablets (5 X 10) Unit Dose
5026805315
NDC 50268-053-15
EXTRA PAIN RELIEF
Acetaminophen, Aspirin (NSAID) and Caffeine
EXTRA STREGTH
50 Tablets (5 X 10) Unit Dose
5026805315
| EXTRA PAIN RELIEF
acetaminophen, aspirin and caffeine tablet, film coated |
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| Labeler - AvPAK (832926666) |
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