EXTRA STRENGTH PAIN RELIEF
-
acetaminophen capsule, liquid filled
DOLGENCORP, LLC
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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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. Severe liver damage may occur if you take:
- more than 8 gelcaps in 24 hours, which is the maximum daily amount
- 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 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 controlled room temperature 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
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Rexall®
Since 1903
EXTRA STRENGTH
Pain Relief
Acetaminophen 500 mg
SEE NEW WARNINGS INFORMATION
•Pain Reliever
•Fever reducer
•Fast release
24 Rapid Release Gelcaps
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 ORG070951908
Visit us at: Rexall.com
or call 1-866-4-REXALL
MANUFACTURED FOR DOLGENCORP, LLC
100 MISSIONS RIDGE
GOODLETTSVILLE, TN 37072 USA
Product Packaging
| EXTRA STRENGTH PAIN RELIEF
acetaminophen capsule, liquid filled |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH NOT FINAL | part343 | 05/10/2004 | |
| Labeler - DOLGENCORP, LLC (068331990) |
Revised: 07/2011 DOLGENCORP, LLC