RxNorm Names
ACETAMINOPHEN tablet, film coated, extended release
[Amerisource Bergen]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0f4d7f1-aa17-4233-bc47-41c280fdd7ce| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
USES
- temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- headache
- minor pain of arthritis
- temporarily reduces fever
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 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
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 or any of the inactive ingredients in this product.
DIRECTIONS
-
do not take more than directed (see overdose warning)
adults and children 12 years and over ▪ take 2 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctorchildren under 12 years ▪ do not use
OTHER INFORMATION
- store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
- see end panel for batch number and expiration date
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
INACTIVE INGREDIENTS
Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
PRINCIPAL DISPLAY PANEL
Compare to Tylenol®8 Hour active ingredient†
acetaminophen extended-release tablets, USP 650 mg
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
- For up to 8 Hour Relief of Minor Muscle Aches & Pain
50 caplets*650 mg EACH (*capsule-shaped tablets)
| ACETAMINOPHEN
acetaminophen tablet, film coated, extended release |
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| Labeler - Amerisource Bergen (007914906) |
| Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Ohm Laboratories Inc. | 184769029 | manufacture(46122-062) | |
Revised: 10/2012
Document Id: 4fef2c61-8322-49ae-8bec-521fe9eb696b
Set id: c0f4d7f1-aa17-4233-bc47-41c280fdd7ce
Version: 1
Effective Time: 20121025
Amerisource Bergen
Review RxNorm Normal Forms