Pain Reliever Extra Strength Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW PROPYLENE GLYCOL STEARIC ACID TITANIUM DIOXIDE L;5
Drug Facts
Composition & Profile
Identifiers & Packaging
Product Packaging NDC 37205-980-78 LEADER® Compare to Extra Strength Tylenol® active ingredient* EXTRA STRENGTH Pain Reliever Acetaminophen 500 mg Pain Reliever/Fever Reducer Rapid Release Gels 100 GELCAPS Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels. 50844 REV0213D51912 DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 CIN 3956810 www.myleader.com 1-800-200-6313 Leader 44-519 Leader 44-519
- Product Packaging NDC 37205-980-78 LEADER® Compare to Extra Strength Tylenol® active ingredient* EXTRA STRENGTH Pain Reliever Acetaminophen 500 mg Pain Reliever/Fever Reducer Rapid Release Gels 100 GELCAPS Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels. 50844 REV0213D51912 DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 CIN 3956810 www.myleader.com 1-800-200-6313 Leader 44-519 Leader 44-519
Overview
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
Indications & Usage
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
Dosage & Administration
Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor 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
Warnings & Precautions
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. 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: 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.
Purpose
Purpose Pain reliever/fever reducer
Do Not Use
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 & Ask a Doctor
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
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.
Storage & Handling
Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
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