CETAL® (Paracetamol / Acetaminophen): Formulations, Dosage, Combinations & Safety

CETAL® (Paracetamol/Acetaminophen) — Updated Professional Drug Commentary

For the Medical Profession Only
Last reviewed: 8 September 2026

1. Disclaimer

This commentary is intended for professional and educational use and is not a substitute for the currently approved Egyptian package leaflet, prescribing information, or individualized medical advice. Product composition, approved indications, age restrictions, pack sizes, availability, and regulatory status may differ between formulations and may change over time. Prescribers and pharmacists should verify the current product-specific information before prescribing, dispensing, or recommending CETAL®.

We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.

2. Summary

CETAL® is a brand family marketed by Egyptian International Pharmaceutical Industries Co. (EIPICO). The core CETAL® products contain paracetamol (acetaminophen) and are used primarily as analgesic and antipyretic agents for mild-to-moderate pain and fever. EIPICO's current product information identifies CETAL® 500 mg tablets, CETAL® 1000 mg tablets, oral drops, oral suspension, 120 mg and 300 mg rectal suppositories, Cetal Extra, and Cetal Cold & Flu among its CETAL® products. (Eipico)

Importantly, not every product carrying the CETAL® name is paracetamol alone. Cetal Extra, Cetal Sinus, Cetal Cold & Flu, and Cetal Cold & Flu Day are combination products containing additional active ingredients. Therefore, the formulation must always be identified before dosing or combining products. (Eipico)

3. Brand Name

CETAL®

Manufacturer: Egyptian International Pharmaceutical Industries Co. (EIPICO), Egypt. EIPICO's current website lists CETAL® products among its human pharmaceutical products. (Eipico)

4. Category

Non-opioid analgesic and antipyretic.

Paracetamol provides analgesic and antipyretic effects with relatively little peripheral anti-inflammatory activity compared with conventional NSAIDs. It should not be regarded as an antimicrobial drug or as a conventional anti-inflammatory NSAID. (NCBI)

5. Active Ingredient

Single-ingredient CETAL® products

Paracetamol (acetaminophen).

Important CETAL® combination products documented in Egyptian sources

• Cetal Extra: Paracetamol 500 mg + caffeine anhydrous 65 mg. (Eipico)
• Cetal Sinus: Paracetamol 500 mg + pseudoephedrine hydrochloride 30 mg. (Eipico)
• Cetal Cold & Flu: Paracetamol 500 mg + pseudoephedrine hydrochloride 30 mg + chlorpheniramine maleate 2 mg. (Eipico)
• Cetal Cold & Flu Day: Paracetamol 500 mg + caffeine anhydrous 25 mg + phenylephrine hydrochloride 5 mg; this formulation appears in the Egyptian Drug Authority's January 2026 OTC list. (Egyptian Drug Authority)

6. Pharmaceutical Form & Strength

The following CETAL® formulations are documented in EIPICO and/or Egyptian regulatory/market sources:

Formulation	Strength / composition	Pack information documented
CETAL® Tablets	Paracetamol 500 mg/tablet	20 tablets; EDA also lists 2 × 10 tablets
CETAL® 1000 mg Tablets	Paracetamol 1000 mg/tablet	EDA lists packs of 5 tablets per strip, with 1–3 strips; 15-tablet packs are therefore documented
CETAL® Oral Drops	Paracetamol 100 mg/mL	15 mL
CETAL® Oral Suspension	Paracetamol 250 mg/5 mL	60 mL
CETAL® Syrup	Paracetamol 120 mg/5 mL	EIPICO country listings document 60 mL and 100 mL presentations; other historical pack sizes have also been listed
CETAL® Rectal Suppositories	Paracetamol 120 mg/suppository	5 suppositories
CETAL® Rectal Suppositories	Paracetamol 300 mg/suppository	5 suppositories
Cetal Extra	Paracetamol 500 mg + caffeine 65 mg	20 caplets/tablets
Cetal Sinus	Paracetamol 500 mg + pseudoephedrine HCl 30 mg	20 caplets
Cetal Cold & Flu	Paracetamol 500 mg + pseudoephedrine HCl 30 mg + chlorpheniramine maleate 2 mg	20 caplets
Cetal Cold & Flu Day	Paracetamol 500 mg + caffeine 25 mg + phenylephrine HCl 5 mg	EDA lists 10-caplet strips, 1 or 2 strips

EIPICO's current website confirms several of the single-ingredient CETAL® presentations, while the Egyptian Drug Authority's January 2026 OTC list specifies the 500 mg and 1000 mg products and pediatric formulations in greater regulatory detail. (Eipico)

The 15-tablet Cetal 1000 mg pack is also currently listed by Egyptian pharmacies, while the EDA regulatory listing documents 1–3 strips of five tablets. (TourCare-Pharmacy)

7. Manufacturer & Marketing Authorization Holder

Manufacturer: Egyptian International Pharmaceutical Industries Co. (EIPICO), Tenth of Ramadan City, 1st Industrial Zone B1, Egypt. (Eipico)

EIPICO's public product materials identify the company with the CETAL® products. The exact marketing-authorization-holder entry for each individual formulation/registration should be confirmed against the current Egyptian Drug Authority registration record or current approved leaflet rather than inferred solely from a commercial website. The publicly available evidence nevertheless clearly identifies EIPICO as the manufacturer and product owner/registrant in its own product documentation. (Eipico)

8. Mechanism of Action

The precise mechanism of paracetamol is not completely established. Its analgesic and antipyretic effects are associated primarily with reduction of prostaglandin synthesis in the central nervous system and modulation of central nociceptive pathways. It has substantially weaker peripheral anti-inflammatory activity than conventional NSAIDs. The historical concept of a human COX-3 mechanism has not been established as a clinically accepted human mechanism. (PubMed)

The antipyretic effect involves action within the hypothalamic temperature-regulating system, reducing the elevated temperature set point associated with fever. (NCBI)

9. Spectrum of Activity

Paracetamol has analgesic and antipyretic activity but does not have antibacterial, antiviral, antifungal, or other antimicrobial activity.

Accordingly, CETAL® may relieve pain or fever associated with infections but does not treat the underlying infection itself. EIPICO's product indications appropriately describe symptomatic treatment of pain and febrile conditions rather than antimicrobial treatment. (Eipico)

10. Pharmacokinetics

Paracetamol is rapidly absorbed following oral administration. Peak plasma concentrations generally occur within approximately 30–120 minutes, depending on formulation and circumstances. Plasma protein binding is relatively low, approximately 10–25%. (NCBI)

It is extensively metabolized, mainly in the liver, by glucuronidation and sulfation. A smaller fraction undergoes cytochrome-P450-mediated oxidation, principally involving CYP2E1, producing the reactive metabolite N-acetyl-p-benzoquinone imine (NAPQI). At therapeutic doses, NAPQI is rapidly detoxified by conjugation with glutathione. (NCBI)

After therapeutic dosing, the plasma half-life is usually around 1.5–3 hours in healthy adults but may be prolonged in hepatic dysfunction, overdose, and some vulnerable populations. Most metabolites are eliminated in the urine, and less than 5% of the drug is excreted unchanged. (PubMed)

Rectal absorption is possible but can be more variable than oral exposure; therefore, oral and rectal doses should not automatically be assumed to be pharmacokinetically interchangeable on a milligram-for-milligram basis. (NCBI)

11. Indications

CETAL® single-ingredient formulations are used for the symptomatic relief of mild-to-moderate pain and/or fever.

Examples include:

• headache and migraine;
• toothache;
• musculoskeletal and other minor pain;
• dysmenorrhea;
• fever associated with common respiratory illnesses and other febrile conditions;
• pain or fever in children when an age- and weight-appropriate formulation is used.

These indications are consistent with current EIPICO product descriptions for CETAL® 500 mg, oral drops, oral suspension, suppositories, and CETAL® 1000 mg. (Eipico)

The previous concept of routine prophylactic paracetamol for several days after childhood vaccination should not be presented as a universal recommendation. Antipyretic use after vaccination should follow current vaccination guidance and the individual clinical situation rather than routine automatic prophylaxis.

12. Administration

Adults and adolescents

For many immediate-release paracetamol products, a usual adult dose is 500–1000 mg every 4–6 hours as required, with at least 4 hours between doses. The generally recognized maximum is 4,000 mg in 24 hours from all paracetamol-containing products, although a lower maximum may be appropriate in patients with low body weight, liver disease, chronic heavy alcohol use, malnutrition, or other risk factors. (nhs.uk)

The 1000 mg CETAL® tablet should be taken as one tablet at a time, and the current Egyptian Drug Authority listing identifies that formulation for adults and children 16 years of age and over. The 500 mg CETAL® tablet is listed by the EDA for adults and children 10 years and over. (Egyptian Drug Authority)

Children

Pediatric dosing should be weight-based and formulation-specific, commonly within the range of approximately 10–15 mg/kg per dose every 4–6 hours, with a maximum of 4 doses in 24 hours or approximately 60 mg/kg/day for routine home use unless a product-specific or clinician-directed regimen differs. Exact dosing must follow the approved leaflet for the particular CETAL® formulation and the child's age and weight. (NCBI)

The January 2026 EDA listing provides formulation-specific populations, including:

• Cetal oral drops 100 mg/mL: birth to 24 months, with specified weight limits in the regulatory entry;
• Cetal oral suspension 250 mg/5 mL: from 2 months in infants meeting the specified weight/gestational criteria;
• Cetal 120 mg suppositories: approximately 1–5 years and 10–18 kg;
• Cetal 300 mg suppositories: approximately 2–9 years and 14–28 kg. (Egyptian Drug Authority)

These specific restrictions are more reliable than applying a generic age-based table to every CETAL® dosage form.

13. Method of Preparation

Tablets/caplets: swallow with water according to the product instructions.

Oral drops: the product is supplied as an oral liquid; use the supplied dropper/measuring device and do not substitute household spoons.

Oral suspension: shake well before each dose to ensure uniform distribution of the suspended drug, and measure with an appropriate graduated device. Do not assume that a suspension and syrup have the same concentration.

Suppositories: remove the wrapper and administer rectally as directed. Do not cut or divide a suppository unless the product's approved instructions specifically permit it.

Combination products: always read the complete ingredient list before administration because additional analgesics, decongestants, antihistamines, or caffeine may be present.

14. Contraindications

The principal contraindication is known hypersensitivity to paracetamol/acetaminophen or any component of the specific product.

Patients with significant hepatic disease require careful clinical assessment rather than being treated as routine users. The contraindications and warnings of combination products may be broader because their additional ingredients have their own contraindications.

15. Warnings & Precautions

The most important safety issue is dose-related hepatotoxicity. Severe liver injury can occur following acute overdose and may initially be clinically silent. Patients must not exceed the recommended dose and must account for paracetamol contained in other prescription or non-prescription products. (MedlinePlus)

Use particular caution in:

• hepatic impairment;
• chronic heavy alcohol use or alcohol dependence;
• malnutrition or prolonged fasting;
• low body weight;
• renal impairment where repeated dosing may require individualized scheduling;
• prolonged or repeated self-medication.

Patients should not take two or more paracetamol-containing products simultaneously unless the total dose has been deliberately assessed. This is particularly important with Cetal Extra, Cetal Sinus, Cetal Cold & Flu, Cetal Cold & Flu Day, and other cold/flu products. (MedlinePlus)

Serious skin reactions

Rare but potentially life-threatening reactions including Stevens–Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis have been associated with acetaminophen. Patients who develop a rash or other signs of hypersensitivity should stop the medicine and seek immediate medical attention. (U.S. Food and Drug Administration)

The former statement that paracetamol is automatically the preferred analgesic in all patients with asthma or aspirin/NSAID intolerance is too broad. Individual patients with analgesic hypersensitivity may have different patterns of reaction and require individualized assessment.

16. Drug Interactions

Clinically relevant interactions include:

Warfarin: repeated use of paracetamol, particularly at higher doses, may increase anticoagulant effect/INR in some patients. Occasional use at usual doses is less likely to produce a clinically important interaction, but prolonged use warrants monitoring where appropriate.

Enzyme-inducing drugs: drugs such as rifampicin, carbamazepine, phenytoin and other enzyme inducers may increase formation of toxic metabolites and may increase hepatotoxic risk, particularly with prolonged or excessive paracetamol exposure.

Alcohol: heavy or chronic alcohol use may increase susceptibility to hepatic injury, especially in the setting of excessive dosing, malnutrition, or prolonged use. (MedlinePlus)

Zidovudine: concurrent use has been associated with increased risk of neutropenia in some clinical contexts and should be medically supervised.

Metoclopramide: may increase the rate of absorption of orally administered paracetamol.

Cholestyramine: may reduce absorption if administered close to paracetamol; separation of administration may be required.

Caffeine: increases the analgesic effect of paracetamol in some combination products and is deliberately incorporated into Cetal Extra and Cetal Cold & Flu Day.

The interaction profile should always be assessed using the complete formulation, not merely the word "Cetal."

17. Side Effects

Paracetamol is generally well tolerated at recommended doses.

Reported adverse effects include:

• nausea and other gastrointestinal symptoms;
• skin rash and hypersensitivity reactions;
• rare angioedema/anaphylactic reactions;
• rare but serious cutaneous reactions such as SJS/TEN/AGEP;
• dose-related hepatic injury, particularly with overdose or inappropriate repeated dosing.

The old description that CETAL® is essentially free of significant adverse effects is therefore too reassuring. Serious adverse events are uncommon at therapeutic doses but are clinically important because of their severity. (U.S. Food and Drug Administration)

18. Use in Special Populations

Pregnancy: Paracetamol may be used during pregnancy when clinically needed. Current European regulatory guidance continues to support use when necessary at the lowest effective dose, for the shortest possible duration, and as infrequently as possible. (European Medicines Agency (EMA))

Breastfeeding: Paracetamol is generally considered compatible with breastfeeding when used at recommended doses.

Neonates and young infants: dosing requires particular care because age-related pharmacokinetic differences exist. Do not extrapolate adult dosing to infants.

Children: use a weight-based, formulation-specific regimen and avoid duplicate paracetamol-containing medicines. The EDA specifies distinct age/weight populations for several CETAL® pediatric formulations. (Egyptian Drug Authority)

Older adults: no universal age-based dose reduction is required solely because of age, but frailty, low body weight, renal impairment, hepatic impairment, malnutrition, or polypharmacy may necessitate individualized dosing.

Hepatic impairment: use cautiously and seek professional guidance regarding dose and dosing interval; severe hepatic disease materially increases the clinical risk associated with paracetamol.

Renal impairment: repeated dosing may require adjustment of the dosing interval depending on severity and overall clinical status.

19. Storage Conditions

A specific current storage temperature for every CETAL® formulation was not independently established from the publicly accessible EIPICO product pages reviewed. Therefore, a temperature such as "below 25°C" should not be inserted unless it is confirmed from the current package/leaflet for that formulation.

Store CETAL® products:

• according to the temperature and storage instructions printed on the current package/leaflet;
• in the original container where applicable;
• protected from inappropriate heat, moisture, and contamination;
• out of the reach and sight of children.

For liquid formulations, keep the container tightly closed and follow the product-specific instructions after opening.

20. Additional Sections

Current Egyptian CETAL® market/regulatory picture

EIPICO's current online product catalogue documents Cetal Extra, Cetal 1000 mg, Cetal 120 mg suppositories, Cetal 300 mg suppositories, Cetal Cold & Flu, Cetal oral drops, and Cetal oral suspension. EIPICO's other product/registered-product pages also document Cetal 500 mg tablets, Cetal Sinus, and Cetal syrup. (Eipico)

The Egyptian Drug Authority's January 2026 OTC list additionally documents:

• Cetal® 500 mg tablets;
• Cetal® 1000 mg tablets;
• Cetal® 300 mg micronized rectal suppositories;
• Cetal® 120 mg micronized rectal suppositories;
• Cetal oral suspension 250 mg/5 mL;
• Cetal oral drops 100 mg/mL;
• Cetal Cold & Flu Day 500 mg/25 mg/5 mg. (Egyptian Drug Authority)

EIPICO's published product list also documents a Cetal solution for IV infusion containing paracetamol 10 mg/mL; however, current retail availability of that IV presentation in the Egyptian market was not independently confirmed, so it should not be assumed to be a currently marketed retail presentation solely from that document. (Eipico)

Overdose and treatment

Paracetamol overdose is a medical emergency, even when the patient initially feels well. Symptoms may be delayed, and the absence of early symptoms does not exclude serious toxicity. (MedlinePlus)

Management requires urgent medical/toxicological assessment, including appropriate timing of plasma paracetamol measurement and liver-related investigations. N-acetylcysteine (NAC) is the specific antidotal treatment and is most effective when started early; treatment should not be unnecessarily delayed when clinical criteria indicate that it is required. (FDA Access Data)

Routine statements recommending gastric lavage as standard treatment are outdated and should not appear in a modern general product commentary. Activated charcoal may be considered in selected early presentations by appropriately trained clinicians, while NAC remains the central antidotal therapy. (Gloucestershire Hospitals NHS Trust)

21. Frequently Asked Questions (FAQ)

Is CETAL® an antibiotic?
No. Paracetamol is an analgesic and antipyretic; it does not eradicate bacterial or viral infections.

Can Cetal 500 mg be taken together with Cetal Extra, Cetal Sinus, or Cetal Cold & Flu?
Generally, not without deliberate calculation and professional advice, because these products already contain paracetamol. Combining them can unintentionally produce a potentially toxic cumulative dose.

Is Cetal 1000 mg simply two Cetal 500 mg tablets?
In terms of paracetamol content, 1000 mg equals two 500 mg tablets, but the products have different approved age/use information and should be administered according to the specific product directions. The current EDA listing identifies Cetal 1000 mg for adults and children 16 years and over. (Egyptian Drug Authority)

Can CETAL® be used during pregnancy?
Paracetamol can be used during pregnancy when clinically necessary, using the lowest effective dose for the shortest appropriate duration. (European Medicines Agency (EMA))

What should be done after a suspected overdose?
Seek emergency medical attention immediately, even if the person has no symptoms. Do not wait for jaundice, abdominal pain, vomiting, or other signs of liver injury to appear. (MedlinePlus)

Does the CETAL® name always mean paracetamol alone?
No. CETAL® is also used for several combination products containing decongestants, antihistamines, or caffeine. The exact product name and composition must therefore be checked before every dose. (Eipico)

22. References

1. Egyptian International Pharmaceutical Industries Co. (EIPICO) — Current human pharmaceutical product catalogue and CETAL® product pages. (Eipico)
2. EIPICO — Cetal 1000 mg product information. (Eipico)
3. EIPICO — Cetal 120 mg suppositories product information. (Eipico)
4. EIPICO — Cetal 300 mg rectal suppositories product information. (Eipico)
5. EIPICO — Cetal oral drops and oral suspension product information. (Eipico)
6. EIPICO Product List — CETAL® strengths and combination formulations. (Eipico)
7. Egyptian Drug Authority (EDA) — OTC List, January 2026, including Cetal 500 mg, Cetal 1000 mg, pediatric formulations, and Cetal Cold & Flu Day. (Egyptian Drug Authority)
8. FDA — Acetaminophen safety information and rare serious skin reactions. (U.S. Food and Drug Administration)
9. MedlinePlus / U.S. National Library of Medicine — Acetaminophen safety and maximum daily exposure. (MedlinePlus)
10. NHS — Current adult paracetamol dosing guidance. (nhs.uk)
11. NCBI Bookshelf / StatPearls — Acetaminophen pharmacokinetics, metabolism, mechanism, and toxicity. (NCBI)
12. European Medicines Agency (EMA) — Current position on paracetamol use during pregnancy. (European Medicines Agency (EMA))
13. NHS clinical toxicology guidance — Current management principles for paracetamol overdose and N-acetylcysteine treatment. (NHS Clinical Guidelines)

Scientific corrections incorporated into this version

The clinically important corrections include replacing the outdated 94% glucuronide/sulfate figure with the modern understanding of glucuronidation, sulfation and NAPQI metabolism; avoiding the unsupported claim that paracetamol simply "blocks pain impulses"; removing routine post-vaccination prophylaxis as a blanket recommendation; correcting the overly broad statement regarding asthma/NSAID contraindications; updating overdose management so that N-acetylcysteine is the principal antidotal therapy rather than routine gastric lavage; adding the now-recognized warning regarding rare serious skin reactions; and distinguishing the multiple current CETAL® combination products from single-ingredient paracetamol formulations. (PubMed Central (PMC))