RxNorm Names
ACETAMINOPHEN tablet, film coated, extended release
[Fred's Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=070569ec-82b1-4b26-b38b-3fb3caf71f19| 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 are allergic to acetaminophen or any of the inactive ingredients in this product.
DIRECTIONS
-
do not take more than directed (see overdose warning)
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 doctorunder 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
| ACETAMINOPHEN
acetaminophen tablet, film coated, extended release |
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| Labeler - Fred's Inc. (005866116) |
| Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Ohm Laboratories Inc. | 184769029 | manufacture(55315-333) | |
Revised: 01/2013
Document Id: 4f70b3db-763c-4719-8111-c0aec85b2c9b
Set id: 070569ec-82b1-4b26-b38b-3fb3caf71f19
Version: 1
Effective Time: 20130109
Fred's Inc.
Review RxNorm Normal Forms