RxNorm Names
Review RxNorm Normal Forms
EXTRA STRENGTH ACETAMINOPHEN
(acetaminophen)
capsule
[Sam's West Inc]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e222f50d-3895-4124-8d92-5c5f4178ce96| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
Uses
- temporarily relieves minor aches and pains due to:
- headache
- backache
- toothache
- the common cold
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 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.
Stop use and ask a doctor if
- 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
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damamge. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
Other information
- store at controlled room temperature 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
caster oil, hypromellose, povidone, sodium starch glycolate*, starch, stearic acid
*may contain this ingredient
PRODUCT PACKAGING
NDC 68196-175-14 pain reliever
SIMPLY RIGHT™
Health Care
extra strength
acetaminophen
acetaminophen caplets, 500 mg
pain reliever / fever reducer
Compare to Extra Strength Tylenol® active ingredient†
non-aspirin
relieves minor aches & pains
500 caplets
actual size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV1012A17514
Distributed by:
SAM'S West, Inc.
Bentonville, AR 72716
Simply Right 44-175
| EXTRA STRENGTH ACETAMINOPHEN
acetaminophen capsule |
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| Labeler - Sam's West Inc (051957769) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 832867894 | MANUFACTURE(68196-175) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 038154464 | PACK(68196-175) | |
