RxNorm Names
ACETAMINOPHEN tablet, film coated, extended release
[Chain Drug Marketing Association Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ded10c13-8a4e-469d-8b34-0d6566be016c| 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
| ACETAMINOPHEN
acetaminophen tablet, film coated, extended release |
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| Labeler - Chain Drug Marketing Association Inc. (011920774) |
| Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Ohm Laboratories Inc. | 184769029 | manufacture(63868-091) | |
Revised: 10/2012
Document Id: 66ada349-e26c-493f-95dd-4ae3a2ba3c30
Set id: ded10c13-8a4e-469d-8b34-0d6566be016c
Version: 1
Effective Time: 20121011
Chain Drug Marketing Association Inc.
Review RxNorm Normal Forms