RxNorm Names
PAIN RELIEVER EXTRA STRENGTH
(acetaminophen)
tablet
[Amerisource Bergen]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5dffb278-f92b-43e0-8558-f9668446f10b| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
NOTE: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.
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor arthritis pain
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
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 ever day while using this product
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.
Directions
- do not take more than directed (see overdose warning)
-
adults and children 12 years and over:
- take 2 tablets every 4 to 6 hours while symptoms last.
- do not take more than 8 tablets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use
Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient
Principal Display Panel
Compare to TYLENOL® Extra Strength active ingredient †
Extra Strength
PAIN RELIEVER
ACETAMINOPHEN 500 mg
pain reliever/ fever reducer
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®
| PAIN RELIEVER
EXTRA STRENGTH
acetaminophen tablet |
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| Labeler - Amerisource Bergen (007914906) |
| Registrant - P and L Development of New York Corporation (800014821) |
Revised: 12/2012
Document Id: 725a7684-d0b3-467f-bcab-762f52f7d74d
Set id: 5dffb278-f92b-43e0-8558-f9668446f10b
Version: 1
Effective Time: 20121226
Amerisource Bergen
Review RxNorm Normal Forms