EXTRA STRENGTH ACETAMINOPHEN- acetaminophen capsule, gelatin coated
Sam's West Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Simply Right 44-519
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks ever 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 damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
- adults and children 12 years and over
- take 2 gelcaps every 4 to 6 hours while symptoms last
- do not take more than 8 gelcaps 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide
Product Packaging
NDC 68196-519-05
rapid release
SIMPLY RIGHT™
extra strength
acetaminophen
acetaminophen gelcaps, 500 mg
pain reliever / fever reducer
Compare to Extra Strength Tylenol® active ingredient†
non-aspirin
relieves minor aches & pains
400 rapid release gelcaps
†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.
50844 REV0213C51905
Distributed by: SAM's West, Inc.
Bentonville, AR 72716
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Simply Right 44-519
| EXTRA STRENGTH ACETAMINOPHEN
acetaminophen capsule, gelatin coated |
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| Labeler - Sam's West Inc (051957769) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(68196-519) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(68196-519) | |