Pain Relief Extra Strength by International Laboratories, LLC
Medically reviewed on April 6, 2017
Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: International Laboratories, LLC
NDC Code: 54458-861
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.
Acetaminophen 500 mg
Pain reliever/fever reducer
- temporarily relieves minor aches and pains due to:
• the common cold
• minor pain of arthritis
• muscular aches
• premenstrual and menstrual cramps
- temporarily reduces fever
Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor of pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients
taking the blood thinning drug warfarin
• pain gets worse or lasts more than 10 days
• new symptoms occur
• fever gets worse or lasts more than 3 days
• redness or swelling is present
These could be signs of a serious condition.
give to children under 3 years of age.
ask a health professional before use.
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.
• do not take more than directed (see overdose warning)
adults and children 12 years and over:
• take 2 caplets every 6 hours while symptoms last
• do not take more than 6 caplets 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: ask a doctor
• store at 20-25ºC (68-77ºF)
carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinzed starch, sodium starch glycolate*, stearic acid
*may contain one or more of these ingredients
|PAIN RELIEF EXTRA STRENGTH
|Labeler - International Laboratories, LLC (023569924)|
|International Laboratories, LLC||023569924||RELABEL(54458-861), REPACK(54458-861)|
|L. Perrigo Company||078716293||MANUFACTURE(54458-861), RELABEL(54458-861), REPACK(54458-861)|
|L. Perrigo Company||006013346||MANUFACTURE(54458-861), RELABEL(54458-861), REPACK(54458-861)|