RxNorm Names
Review RxNorm Normal Forms
ACETAMINOPHEN tablet, film coated, extended release
[Safeway Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0eb865a6-229e-452d-a6a9-eb213018d192| 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.
Stop use and ask a doctor if
- the tablet got stuck in your throat
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
Keep out of reach of children.
Overdose warning: Taking more then the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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
| ACETAMINOPHEN
acetaminophen tablet, film coated, extended release |
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| Labeler - Safeway Inc. (009137209) |
| Registrant - Ohm Laboratories Inc. (051565745) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Ohm Laboratories Inc. | 184769029 | manufacture(21130-760) | |
Revised: 09/2012
Document Id: 0a02ebb4-0d21-4159-b143-54662c512451
Set id: 0eb865a6-229e-452d-a6a9-eb213018d192
Version: 2
Effective Time: 20120926
Safeway Inc.
