ADOL CAPLETS PARACETAMOL 500MG 48CAP

Indications

Approved Uses

Symptomatic relief of mild to moderate pain and reduction of fever (antipyretic).

Off-Label Uses

None to list for this OTC product entry (paracetamol is commonly used for osteoarthritis pain, but this is generally within symptomatic pain relief rather than a distinct off-label use for an OTC listing).

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥12 years: 500-1000 mg every 4-6 hours as needed; maximum 4,000 mg/day (lower maximum in hepatic risk factors). Children: dose by weight (10-15 mg/kg per dose every 4-6 hours; max 60 mg/kg/day, not exceeding 4 doses/24 h).

Initial Dose

500mg-1000mg

Maintenance Dose

500mg-1000mg every 4-6 hours as needed

Maximum Dose

4000mg per 24 hours in healthy adults; reduce maximum dose by 50-75% in patients with hepatic impairment or history of alcohol abuse.

Children's Dosage

Children 2-12 years: 10-15mg/kg/dose every 4-6 hours, max 5 doses in 24 hours. Children under 2 years: use only under medical supervision. Neonates: 10-15mg/kg/dose every 6-8 hours

Dose Adjustment Notes

Renal impairment: if CrCl <30 mL/min, extend dosing interval (e.g., every 6-8 hours) and keep within maximum daily dose. Hepatic impairment/chronic alcohol use/malnutrition/low body weight: use the lowest effective dose and consider a reduced maximum daily dose (often ≤2-3 g/day) and avoid prolonged use. Maintain at least 4 hours between doses.

How to Take

Oral: swallow the 500 mg tablet/caplet with water; may be taken with or without food. Do not exceed the labeled dose; do not take with other paracetamol-containing products.

Side Effects

Common Side Effects

Usually none at recommended doses; rare: nausea, vomiting, rash/urticaria (hypersensitivity).

Side Effect Frequency

Rare: nausea, vomiting, rash/urticaria (hypersensitivity). Very rare: serious skin reactions (SJS/TEN), blood dyscrasias. Hepatotoxicity is primarily overdose-related (rare at recommended doses).

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol or any excipients; severe hepatic impairment or severe active liver disease.

Warnings & Precautions

Do not exceed recommended dose (max 4 g/day in adults with normal liver function); avoid concurrent use with other paracetamol-containing products; use caution/seek advice in hepatic disease, chronic alcohol use, malnutrition/low body weight, dehydration, and severe renal impairment; stop and seek care if rash or hypersensitivity occurs; seek urgent care after any suspected overdose even if asymptomatic; consult a clinician if symptoms persist (e.g., pain >3 days or fever persists).

Age Restriction

No specific age restriction for paracetamol as an active ingredient; however, this 500 mg tablet/caplet strength is generally intended for adults and adolescents (commonly ≥12 years). For children <12 years, use age/weight-appropriate pediatric formulations; for <2 years, use only under medical advice.

Drug Interactions

Drug Interactions

Warfarin/coumarins (INR may increase with regular/prolonged paracetamol use); enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (increased hepatotoxicity risk); alcohol/chronic heavy use (increased hepatotoxicity risk); cholestyramine (reduced absorption if given close together); metoclopramide/domperidone (increased absorption rate).

Interaction Severity

MAJOR: Excess/chronic alcohol use (increased hepatotoxicity risk); other paracetamol-containing products (overdose risk). MODERATE: Warfarin (regular use may increase INR/bleeding risk); enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (increased hepatotoxicity risk). MINOR: Cholestyramine (reduced absorption-separate by ≥1 hour); metoclopramide/domperidone (faster absorption).

Food Interaction

No restriction

Alcohol Interaction

Dangerous

Special Populations

Children

Children 2-12 years: 10-15mg/kg/dose every 4-6 hours, max 5 doses in 24 hours. Children under 2 years: use only under medical supervision. Neonates: 10-15mg/kg/dose every 6-8 hours

Elderly

Standard adult dosing; however, consider reducing maximum daily dose to 3000mg/day in frail elderly patients or those with low body weight

Liver Impairment

Use with caution in hepatic impairment; in chronic liver disease/cirrhosis consider reducing maximum total daily dose to 2 g/day and avoid use in severe active liver disease unless specifically directed/monitored by a clinician.

Storage & Patient Advice

Missed Dose

If needed regularly and a dose is missed, take it when remembered; if it is close to the next dose, skip the missed dose and resume the usual schedule. Do not double doses.

Stopping the Medicine

No tapering is required. May be stopped when no longer needed. If used regularly for several days or longer, avoid exceeding the recommended dose and seek medical advice if symptoms persist or if frequent/long-term use is needed.

Overdose

Early symptoms may be absent or include nausea, vomiting, diaphoresis, and abdominal pain; serious hepatotoxicity can develop 24-72 hours after ingestion (jaundice, coagulopathy, hepatic failure). Management: urgent emergency assessment, consider activated charcoal if within ~1 hour of a significant ingestion, and administer N-acetylcysteine (NAC) as the specific antidote as early as possible (most effective within 8-10 hours, but beneficial later).

Patient Counseling

Do not exceed the recommended dose (max 4 g/day in adults unless advised lower); keep at least 4 hours between doses. Do not use with any other paracetamol/acetaminophen-containing products. Avoid or limit alcohol; seek medical advice if chronic alcohol use, liver disease, malnutrition, or low body weight. Seek urgent care immediately after overdose even if asymptomatic. If symptoms persist (e.g., fever >3 days or pain >5 days), consult a clinician.

Monitoring Requirements

No routine monitoring required at therapeutic doses. Monitor liver function tests in patients with pre-existing hepatic disease or prolonged use at high doses

Pharmacology

Mechanism of Action

Inhibits prostaglandin synthesis in the central nervous system (CNS) and peripherally blocks pain-impulse generation. It produces an antipyretic effect by acting on the hypothalamic heat-regulating center.

Onset of Action

30-60 minutes

Half-Life

1-3 hours

Bioavailability

70-90%

Metabolism

Primarily hepatic metabolism via glucuronidation and sulfation; a small fraction undergoes CYP-mediated oxidation (mainly CYP2E1, also CYP1A2/3A4) to NAPQI, detoxified by glutathione at therapeutic doses.

Excretion

Primarily renal excretion as metabolites (glucuronide/sulfate conjugates); a small fraction is excreted unchanged (typically <5%).

Protein Binding

10-25%

Product Information

Available Dosage Forms

Tablet, Capsule, Caplet, Orally disintegrating tablet, Effervescent tablet, Oral suspension, Oral solution, Oral drops, Powder for oral solution, Suppository, Intravenous infusion

Composition per Dose

Each caplet: 500mg paracetamol

Generic Availability

Yes

OTC Alternatives

Ibuprofen (NSAID) and aspirin (adults only) are common OTC alternatives for pain/fever; diclofenac low-dose may be available OTC in some markets but is jurisdiction-dependent.

Pain Type

General

Nsaid

No

Opioid

No

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