Acetaminophen

Temporary relief of minor pain, including headache, toothache, backache, muscle aches, menstrual pain, and minor arthritis pain; reduction of fever.

For IV indications and dosing, consult the linked prescribing information. Oral OTC directions do not apply.

These directions belong to this specific product. A 4,000 mg total daily ceiling is not permission to exceed its 3,000 mg label limit.

For the linked Tylenol 8HR product: 1,300 mg (two caplets) every 8 hours with water; no more than six caplets (3,900 mg) in 24 hours. Swallow whole. Do not split, crush, chew, or dissolve. Do not use for more than 10 days without physician direction. Children under 12: do not use this product.

The linked Children’s Tylenol product uses the chart below. Prefer weight when known. Repeat every 4 hours as needed, with no more than five doses in 24 hours. Shake well and use the enclosed dosing cup. Under age 2 years or under 24 lb: ask a doctor.

Liver disease warrants clinician review before oral use. The IV label contraindicates severe hepatic impairment or severe active liver disease. For severe renal impairment (creatinine clearance ≤30 mL/min), longer intervals and a lower total daily dose may be warranted; follow the product label and individualized plan.

Do not use with known acetaminophen or product-ingredient allergy. A prior serious acetaminophen skin reaction precludes re-exposure. Severe hepatic impairment or severe active liver disease is a contraindication in the IV label.

Acetaminophen injection carries a boxed warning for medication errors and hepatotoxicity. Check mg versus mL, weight-based dosing, pump settings, and total exposure across products and routes. The oral OTC product instead carries Drug Facts liver and allergy warnings.

Serious reactions include liver injury, anaphylaxis, and severe cutaneous reactions. Jaundice, dark urine, or upper abdominal pain requires assessment. In adult IV trials, commonly reported events included nausea, vomiting, headache, and insomnia; these trial frequencies should not be applied to oral OTC use.

• Other acetaminophen products: additive exposure increases overdose risk. Check for APAP on prescription labels.
• Warfarin: sustained use can increase INR; arrange monitoring with the treating clinician.
• Alcohol: review consumption and hepatic risk before treatment.

Discuss the indication, dose, and duration with the obstetric clinician. FDA’s September 2025 communication raised a possible association with neurodevelopmental outcomes but states that causation has not been established. ACOG’s advisory states that current evidence does not support a causal link and supports judicious use when clinically needed.

LactMed considers acetaminophen an appropriate option for pain and fever during breastfeeding. Milk exposure is substantially below usual infant treatment doses; reported adverse infant effects are uncommon.

Use a pediatric product and its weight-based directions for children. For older adults, reconcile combination medicines and assess liver disease, alcohol exposure, and renal function before selecting a regimen.

The exact analgesic and antipyretic mechanism remains incompletely defined; central actions are thought to predominate.

Metabolism

Hepatic glucuronidation and sulfation; a smaller oxidative pathway forms NAPQI, normally detoxified by glutathione.

Elimination

Predominantly urinary metabolites.

Half-life

Mean 2.4 hours in the adult IV study; varies with population and clinical condition.

• Track pain or temperature response and the total daily acetaminophen dose.
• Reassess persistent or worsening symptoms. Adult pain beyond 10 days or fever beyond 3 days warrants clinician review.
• Monitor INR when clinically indicated with warfarin; evaluate hepatic concerns promptly.

• Check every medicine for acetaminophen or APAP before combining products.
• Take only the labeled dose and interval. Do not double a missed dose.
• Liquids: verify concentration, shake suspensions, and use the supplied measuring device.
• For suspected overdose, call U.S. Poison Control at 1-800-222-1222 immediately, even if feeling well. Call 911 for collapse, seizure, impaired breathing, or inability to awaken.

Other manufacturers’ tablets may differ. Confirm the imprint and packaging with a pharmacist.

Dosage form / strength

Film-coated oral caplet · 500 mg

Label packager

Kenvue Brands LLC

Appearance

White, oval, unscored · 19 mm

Imprint

TYLENOL · 500

Example package NDC

50580-378-02 · 100 caplets

Immediate-release oral

500 mg caplets in the representative product above.

Extended-release oral

650 mg caplets in the linked Tylenol 8HR product.

Pediatric oral liquid

160 mg / 5 mL in the linked Children’s Tylenol suspension.

Intravenous

10 mg/mL in the linked injection label; professional administration required.

Additional forms

Other tablet strengths, chewables, liquids, powders, and rectal suppositories have their own product labels.

The representative 500 mg caplet label specifies 20–25°C (68–77°F). Retain original packaging and keep medicines out of children’s sight and reach. Check each formulation’s storage instructions.