TYLENOL Tablets, Capsule, Suspension, Powder (2021)
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Περιεχόμενα
Name of the medicinal product
TYLENOL Regular Strength (DIN 00559393): Acetaminophen Tablets USP 325 mg. TYLENOL Regular Strength Caplets (DIN 00723894): Acetaminophen Tablets USP 325 mg. TYLENOL Extra Strength (DIN 00559407): Acetaminophen ...
Summary product information
<b>Table 1. Product Information:</b> Route of Administration Dosage Form/Strength Clinically Relevant<br>Inactive Ingredients Oral Suspension / 80 mg/1 mL Alcohol-, gluten-, lactose-, sucrose-, sulfite- ...
Indications and clinical use
As an analgesic-antipyretic for the temporary relief of mild to moderate pain in a wide variety of conditions involving musculoskeletal pain, as well as in other painful disorders such as headache pain ...
Contraindications
Hypersensitivity to acetaminophen or to the ingredients of this formulation (see Dosage Forms, Composition and Packaging). Allergic reactions (primarily skin rash) or reports of hypersensitivity secondary ...
Warnings and precautions
General Adults and children 12 years and older should not exceed 4 g/day of acetaminophen or use more than one product containing acetaminophen at a time. Children under 12 years should not be given more ...
Adverse reactions
Central Nervous System Effects Acetaminophen at recommended doses has no obvious effects on central nervous system function<sup>21</sup>. In an overdose situation, central nervous system effects are uncommon. ...
Drug interactions
Analgesics Caution is recommended when analgesic products are used in combination because of possible increases in adverse events (e.g. nephrotoxicity, gastrointestinal lesions, bleeding). Alcohol Studies ...
Dosage and administration
Immediate Release Adults and children 12 years of age and older <u>325 mg tablet/caplet or liquid gel capsule:</u> Take 1 every 4 to 6 hours. If pain or fever does not respond to 1 tablet/caplet or liquid ...
Overdosage
Symptoms and Treatment Acetaminophen: Typical Toxidrome: Hepatic injury is the principal toxic effect of a substantial acetaminophen overdose. In adults and adolescents (12 years of age and older), hepatic ...
Action and clinical pharmacology
Mechanism of Action Acetaminophen is a centrally acting analgesic and antipyretic drug. Although the precise mechanism of action is not totally understood, work by Boutaud<sup>86</sup> suggests acetaminophen ...
Storage and stability
Store at room temperature (15 to 30°C). TYLENOL Rapid Release (Gelcaps) should additionally be protected from high heat and humidity. Infants' and Childrens TYLENOL Suspensions should additionally be protected ...
Dosage forms, composition and packaging
Adults Tablets <u>TYLENOL Regular Strength (325 mg Tablets):</u> Each round, white tablet, engraved TYLENOL on one side and 325 on the other side, contains: acetaminophen 325mg. Inactive ingredients: cellulose, ...
Marketing authorization holder
McNeil Consumer Healthcare division of Johnson & Johnson Inc., 88 McNabb Street, Markham, Ontario, L3R 5L2
Date of approval
September 2, 2005
Date of revision
June 15, 2021
References
1. Forrest JA, Adrianenssens P, Finlayson ND, Prescott LF. Paracetamol metabolism in chronic liver disease. Eur J Clin Pharmacol. 1979;15:427-431. 2. Al-Obaidy SS, McKiernan PJ, Li Wan Po A, Glasgow JF, ...
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