INN monograph
Aspirin / paracetamol /caffeine
Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC] · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Non-opioid analgesic / antipyretic)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [Aspirin] Active peptic ulcer / GI bleeding.
- Severe heart failure.
- NSAID-exacerbated respiratory disease (aspirin-sensitive asthma) for non-selective agents.
- Third trimester pregnancy (ductus arteriosus, oligohydramnios — class warning).
- Severe renal impairment for many agents.
- Hypersensitivity to NSAIDs. [paracetamol] Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid. [caffeine] Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC.
Precautions
- Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.
- When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
- Allergy alert : Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
- The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. if you have ever had an allergic reaction to his product or any of its ingredients Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if an allergic reaction occurs.
- Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stool have stomach pain that does not get better pain gets worse or lasts more than 10 days redness or swelling is present ringing in the ears or loss of hearing occurs new symptoms occur These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use.
- It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Keep out of reach of children.
- In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Point of care
Dosing
Adult
Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Generally safe; prolonged high dose rare associations — prefer careful use in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
PRIMARY toxicity organ in overdose; therapeutic doses usually safe if daily limits respected.
Safety
Drug interactions
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Aspirin, Paracetamol, Caffeine Citrate.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- [Aspirin] Dyspepsia, nausea, fluid retention, raised BP.
- Serious: peptic ulcer/bleed, AKI, heart failure exacerbation, severe skin reactions, bronchospasm, hepatitis (rare). [paracetamol] Rare at therapeutic doses.
- Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP). [caffeine] Adverse reactions vary by agent.
- Counsel on common predictable effects and serious warning symptoms (allergy, severe rash, jaundice, unusual bleeding, severe GI symptoms, neurological changes).
- Report suspected ADRs via national pharmacovigilance channels.
Use
Indications
- Uses for the temporary relief of minor aches and pains or as recommended by your doctor.
- Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin
Pharmacology
Mode of action
Inhibitors of cyclo-oxygenase [COX-1 and COX-2] enzyme that catalyzes the conversion of arachidonic acid to PGH2.
Full mechanism text
Inhibitors of cyclo-oxygenase [COX-1 and COX-2] enzyme that catalyzes the conversion of arachidonic acid to PGH2. Paracetamol inhibits central prostaglandin synthesis via effects on cyclo-oxygenase pathways (including COX-2 preferential central effects) and may engage serotonergic descending pathways. Antipyretic effect via hypothalamic heat-regulating centre. Minimal peripheral anti-inflammatory action.
ADME
Pharmacokinetics & PD
| Onset | 30–60 minutes oral |
|---|---|
| Duration | 4–6 hours |
| Route | ORAL / RECTAL / IV |
| Metabolism | (glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted. |
| Half-life | ~2–3 h; prolonged in liver disease/overdose. |
Full PK/PD text
Rapid oral absorption. Hepatic metabolism (glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted. Half-life ~2–3 h; prolonged in liver disease/overdose.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
[Aspirin] Avoid in third trimester. Earlier pregnancy: use only if needed; prefer paracetamol first-line. [paracetamol] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration. [caffeine] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.
Lactation
[Aspirin] Short-course ibuprofen generally acceptable; avoid chronic high-dose/long half-life agents when possible. [caffeine] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Non-opioid analgesic / antipyretic)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.