PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, coated
Chain Drug Marketing Association
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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Active ingredient (in each tablet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- 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 tablets (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 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
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 tablets every 6 hours while symptoms last
- swallow whole – do not crush, chew, or dissolve
- do not take more than 6 tablets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
|
| children under 12 years |
|
Other information
- store between 20-25°C (68-77°F)
- retain carton for complete product information
Inactive ingredients
acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
PRINCIPAL DISPLAY PANEL
NDC 63868-507-01
QUALITY CHOICE
†Compare to TYLENOL® Extra Strength EZ Tabs active ingredient
Extra Strength
Pain Relief Easy Tabs
SEE NEW WARNINGS & DIRECTIONS
Pain Reliever / Fever Reducer
Acetaminophen
Sweet Coated
Easy to Swallow
100 Tablets – 500 mg each
