EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, liquid filled
PuraCap Pharmaceutical 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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Active ingredient (in each softgel)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
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- 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. 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
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do not take more than directed (see Overdose warning)
|
adults and children 12 years of age and over
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- take 2 softgels every 6 hours while symptoms last
- do not take more than 6 softgels in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
|
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children under 12 years of age
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ask a doctor
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Other information
-
store at room temperature 15°-30°C (59°-86°F)
Inactive ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink
Questions or comments?
send inquiries to: Demoulas Supermarkets Inc., 875 East Street, Tewksbury, MA 01876
PRINCIPAL DISPLAY PANEL
MARKET BASKET EXTRA STRENGTH PAIN RELIEF
ACETAMINOPHEN 500 mg 40 LIQUID GELS
NDC 51013-128-25
*Compare to the active ingredient in TYLENOL® Extra Strength
