RxNorm Names
ACETAMINOPHEN tablet, film coated, extended release
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Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=80310ab1-f10f-4881-b31a-fa156db8e474| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
USES
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- headache
- toothache
- the common cold
- premenstrual and menstrual cramps
- 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
DIRECTIONS
| adults |
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 doctor |
| under 18 years of age | ask a doctor |
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
AcetaminophenCaplets*650 mg Extended-Release Tablets, USP
24 Caplets* 650 mg each (*capsule-shaped tablets)
For the Temporary Relief of Minor Arthritis Pain
٭Compare to the active ingredient of TYLENOL®ARTHRITIS PAIN
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
| ACETAMINOPHEN
acetaminophen tablet, film coated, extended release |
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| Labeler - Select Brand (043562370) |
| Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Ohm Laboratories Inc. | 184769029 | manufacture(15127-332) | |
Revised: 10/2012
Document Id: 52cde4d1-9930-4d53-9c28-2dcc281867d2
Set id: 80310ab1-f10f-4881-b31a-fa156db8e474
Version: 1
Effective Time: 20121002
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Review RxNorm Normal Forms