Acetaminophen

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Boxed warning

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that: the dose in milligrams (mg) and milliliters (mL) is not confused; the dosing is based on weight for patients under 50 kg; infusion pumps are properly programmed; and the total daily dose of acetaminophen from all sources does not exceed maximum daily limits. Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than one acetaminophen-containing product [see Warnings and Precautions ( 5.1 ) ]. WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY See full prescribing information for complete boxed warning. Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. ( 5.3 ) Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product. ( 5.1 )

Warnings

Liver Warning: "Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours" (the maximum daily dose), when combined with other acetaminophen-containing drugs, or with 3+ daily alcoholic drinks. Allergy Alert: The product "may cause severe skin reactions" with symptoms including skin reddening, blisters, and rash; users should "stop use and seek medical help right away" if these occur. Additional Warnings: - Do not use with other acetaminophen-containing products - Ask a doctor before use if you have liver disease - Stop use if pain lasts over 10 days or fever over 3 days - Contains overdose warning regarding liver damage risk

Contraindications

4 CONTRAINDICATIONS Acetaminophen is contraindicated: in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation. in patients with severe hepatic impairment or severe active liver disease [see Warnings and Precautions (5.1) ]. Acetaminophen is contraindicated: In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation. ( 4 ) In patients with severe hepatic impairment or severe active liver disease. ( 4 )

Overdose

Overdose warning: 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.

Drug interactions

7 DRUG INTERACTIONS Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. ( 7.1 ) Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. ( 7.2 ) 7.1 Effects of Other Substances on Acetaminophen Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. The clinical consequences of these effects have not been established. Effects of ethanol are complex, because excessive alcohol usage can induce hepatic cytochromes, but ethanol also acts as a competitive inhibitor of the metabolism of acetaminophen. 7.2 Anticoagulants Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. As no studies have been performed evaluating the short-term use of Acetaminophen Injection in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances.

Uses

This product is indicated to "temporarily relieve minor aches and pains" including headache, muscular aches, backache, minor arthritis pain, common cold symptoms, toothache, and menstrual cramps. It also "temporarily reduces fever."

Dosage forms & strengths

Capsule, Liquid Filled Tablet Tablet, Film Coated TABLET, COATED TABLET LIQUID INJECTION, SOLUTION CHEWABLE GEL TABLET, FILM COATED SUSPENSION CAPSULE, LIQUID FILLED TABLET, CHEWABLE POWDER SOLUTION TABLET, FILM COATED, EXTENDED RELEASE TABLET, EXTENDED RELEASE KIT INJECTION SUPPOSITORY CAPSULE SYRUP TABLET, ORALLY DISINTEGRATING CAPSULE, GELATIN COATED GEL GRANULE BAR, CHEWABLE TABLET, EFFERVESCENT CAPSULE, COATED GRANULE, FOR SOLUTION

ACETAMINOPHEN 300 mg CODEINE PHOSPHATE 15 mg CODEINE PHOSPHATE 30 mg CODEINE PHOSPHATE 60 mg ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE 4 mg PHENYLEPHRINE HYDROCHLORIDE 10 mg DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN 500 mg CAFFEINE 65 mg Acetaminophen 325 mg BUTALBITAL 50 mg / ACETAMINOPHEN 500 mg / CAFFEINE 40 mg BUTALBITAL 50 mg CAFFEINE 40 mg PENTAZOCINE HYDROCHLORIDE 25 mg ACETAMINOPHEN 650 mg SODIUM STARCH GLYCOLATE TYPE A CORN 3.61 mg POVIDONE K30 5.415 mg STEARIC ACID 1.805 mg ACETAMINOPHEN 324.9 mg STARCH, CORN 25.27 mg ACETAMINOPHEN 500 mg/1 ACETAMINOPHEN 325 mg/1 ACETAMINOPHEN 160 mg/5mL ACETAMINOPHEN 10 mg/mL ACETAMINOPHEN 80 mg/1 ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL ACETAMINOPHEN 650 mg/1 ACETAMINOPHEN 1 kg/kg ACETAMINOPHEN 1 g/g ACETAMINOPHEN 25 kg/25kg ACETAMINOPHEN 500 mg/.95g ACETAMINOPHEN 160 mg/1 ACETAMINOPHEN 1000 mg/30mL ACETAMINOPHEN 500 mg/15mL ACETAMINOPHEN 120 mg/1 ACETAMINOPHEN 325 mg/10.15mL ACETAMINOPHEN 650 mg/20.3mL ACETAMINOPHEN 1000 mg/100mL ACETAMINOPHEN .5 g/24g ACETAMINOPHEN .95 kg/kg ACETAMINOPHEN 499.5 mg/1 ACETAMINOPHEN 1 kg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 ACETAMINOPHEN 250 mg/1 ACETAMINOPHEN 92 kg/100kg ACETAMINOPHEN 100 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 IBUPROFEN 125 mg/1 ACETAMINOPHEN 900 mg/kg ACETAMINOPHEN 960 mg/30mL ACETAMINOPHEN 675 mg/15mL ACETAMINOPHEN 50 kg/50kg ACETAMINOPHEN .5 g/g GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1

Directions do not take more than directed 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 take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor

Ingredients

Active:

Active ingredient (in each caplet) Acetaminophen 500 mg

Inactive:

Inactive ingredients castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid