Ezamol-C Tablets (Paracetamol, Phenylephrine, Caffeine): Cold & Flu Dosage, Uses & Safety

EZAMOL-C Tablets — Comprehensive Drug Information

1. Disclaimer

This information is provided for general educational and informational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider or pharmacist before starting, stopping, or changing any medication.

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

Ezamol-C is an Egyptian over-the-counter multi-symptom oral tablet used for the short-term relief of the common cold, influenza, and sinusitis. Each tablet combines an analgesic-antipyretic (paracetamol), a mild CNS stimulant (caffeine), a decongestant (phenylephrine HCl), an expectorant (terpin hydrate), and vitamin C (ascorbic acid) to address fever, aches, nasal congestion, productive cough, and vitamin C depletion associated with febrile illness.

3. Brand Name

Ezamol-C (Ezamol – C Tablets).

4. Category

Cold, cough, flu, and sinusitis combination preparations (OTC symptomatic cold/flu remedies).

5. Active Ingredients

Each film-coated tablet contains:

• Paracetamol (Acetaminophen) 500 mg
• Phenylephrine HCl 5 mg
• Caffeine 25 mg
• Terpin hydrate 20 mg
• Ascorbic acid (Vitamin C) 30 mg

6. Pharmaceutical Form & Strength

Oral film-coated tablets containing the fixed-dose combination listed above. Marketed pack: 2 strips × 10 tablets = 20 tablets per box.

7. Manufacturer & Marketing Authorization Holder

Manufactured by Multi-Apex for Pharmaceutical Industries – S.A.E., Badr City, Egypt. Marketing authorization is held by the same company in the Egyptian market.

8. Mechanism of Action

• Paracetamol: Central inhibition of prostaglandin synthesis (predominantly via COX-2 in the CNS) producing analgesic and antipyretic effects.
• Phenylephrine HCl: Direct-acting α1-adrenergic agonist causing vasoconstriction of nasal mucosal blood vessels, reducing mucosal edema and nasal stuffiness.
• Caffeine: Non-selective adenosine receptor antagonist; produces mild CNS stimulation, reduces fatigue, and may enhance the analgesic effect of paracetamol.
• Terpin hydrate: Traditional expectorant that mildly increases bronchial secretions, aiding mucus clearance.
• Ascorbic acid (Vitamin C): Water-soluble vitamin acting as an antioxidant and cofactor for collagen synthesis; supplements requirements that may increase during infection.

9. Spectrum of Activity

Not an anti-infective; the product does not act against viruses or bacteria. It provides symptomatic relief of upper respiratory tract symptoms — fever, headache, generalized aches, nasal congestion, and mild productive cough — associated with colds, influenza, and sinusitis.

10. Pharmacokinetics

• Paracetamol: Rapidly absorbed orally; peak plasma level ~30–60 min; hepatic metabolism (glucuronidation, sulfation, minor CYP2E1 pathway to reactive NAPQI); half-life ~1–4 h; renal excretion of metabolites.
• Phenylephrine (oral): Extensive first-pass metabolism (mainly by intestinal monoamine oxidase and sulfation); oral bioavailability is low (~38% or less); half-life ~2–3 h; renal excretion.
• Caffeine: Rapidly and completely absorbed; peak 15–45 min; hepatic metabolism by CYP1A2; half-life ~3–7 h (prolonged in pregnancy, neonates, and hepatic impairment).
• Terpin hydrate: Absorbed orally; partially metabolized in the liver and excreted in urine and bronchial secretions.
• Ascorbic acid: Absorbed in the small intestine via active transport (saturable); widely distributed; renal excretion of excess.

11. Indications

• Symptomatic relief of common cold, influenza, and sinusitis.
• Relief of mild to moderate aches, headache, and pain.
• Reduction of fever.
• Relief of nasal congestion associated with upper respiratory infections.
• Supplementation of vitamin C during cold and flu episodes.

12. Administration

• Adults: 2 tablets orally, up to 4 times daily (do not exceed 8 tablets in 24 hours, which corresponds to the maximum 4 g/day of paracetamol).
• To be taken with water or a warm drink, ideally at the first sign of a cold or flu.
• Not recommended for children unless specifically directed by a physician (the product is labelled for adult use).

13. Method of Preparation

No preparation, reconstitution, or dilution is required. The tablet is swallowed whole with fluid. It may be taken with or without food; taking with food may reduce the risk of nausea.

14. Contraindications

• Known hypersensitivity to paracetamol, phenylephrine, caffeine, terpin hydrate, ascorbic acid, or any excipient.
• Severe hepatic impairment or active hepatic disease.
• Severe renal impairment.
• Severe hypertension, significant cardiovascular disease, coronary artery disease, or tachyarrhythmia (due to phenylephrine).
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping them.
• Hyperthyroidism, pheochromocytoma, narrow-angle glaucoma.
• Concurrent use of other paracetamol- or phenylephrine-containing products.

15. Warnings & Precautions

• Use with caution in patients with impaired hepatic or renal function.
• Do not exceed the recommended daily dose; paracetamol overdose can cause severe, potentially fatal hepatotoxicity even when initial symptoms are mild.
• Avoid alcohol during treatment; chronic alcohol use increases the risk of paracetamol-related liver injury.
• Use with caution in diabetes mellitus, benign prostatic hyperplasia, urinary retention, or closed-angle glaucoma (phenylephrine).
• Caffeine content may cause insomnia, restlessness, palpitations, or nervousness; patients should limit additional caffeine intake.
• High doses of vitamin C may increase the risk of oxalate kidney stones in predisposed individuals.
• Discontinue and seek medical advice if symptoms persist beyond a few days, or if high fever, rash, or breathing difficulty develops.
• Regulatory note: In 2024–2025, the U.S. FDA proposed removing oral phenylephrine from the OTC nasal decongestant monograph based on evidence that oral phenylephrine at recommended doses is not effective as a nasal decongestant; the finding relates to efficacy, not safety. Egyptian and other regulators continue to authorize the ingredient.

16. Drug Interactions

• MAOIs and within 14 days of their withdrawal: Risk of hypertensive crisis with phenylephrine — contraindicated.
• Tricyclic antidepressants, ergot alkaloids, other sympathomimetics, methyldopa, β-blockers: Enhanced pressor effect of phenylephrine.
• Warfarin and other coumarin anticoagulants: Prolonged regular use of paracetamol may enhance the anticoagulant effect (increased INR).
• Enzyme-inducing drugs (rifampicin, phenytoin, carbamazepine, phenobarbital, isoniazid) and chronic alcohol: Increase risk of paracetamol hepatotoxicity.
• Metoclopramide, domperidone: Increase paracetamol absorption; cholestyramine: decreases it.
• Chloramphenicol: Paracetamol may prolong its half-life.
• Fluoroquinolones (e.g., ciprofloxacin), cimetidine, oral contraceptives, fluvoxamine: Reduce caffeine clearance (increased CNS effects).
• Lithium, theophylline, clozapine: Caffeine can alter levels or effects.
• Deferoxamine: Ascorbic acid may increase tissue iron toxicity.
• Iron salts: Vitamin C enhances non-heme iron absorption.

17. Side Effects

Generally well tolerated at recommended doses. Reported effects include:

• Common/uncommon: Nausea, vomiting, epigastric discomfort (especially on an empty stomach), mild headache, insomnia, nervousness, palpitations, and mild elevation of blood pressure.
• Rare: Skin rash, urticaria, and other hypersensitivity reactions; blood disorders (thrombocytopenia, leukopenia, agranulocytosis) with prolonged use; acute pancreatitis reported rarely.
• Very rare/serious: Severe skin reactions (Stevens–Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) reported with paracetamol; hepatotoxicity with overdose.
• Genitourinary: Urinary retention (especially in men with prostatic enlargement) from phenylephrine.

Seek immediate medical attention for signs of allergic reaction, jaundice, unusual bleeding or bruising, severe rash, or chest pain.

18. Use in Special Populations

• Pregnancy: Not routinely recommended without medical advice. Paracetamol at therapeutic doses is generally considered the analgesic-antipyretic of choice in pregnancy, but phenylephrine and caffeine are best avoided, especially in the first trimester, due to potential vasoconstrictive effects and possible association with low birth weight at high caffeine intakes.
• Breastfeeding: Paracetamol is compatible; phenylephrine may reduce milk production and pass into breast milk in small amounts; caffeine passes into breast milk and may cause infant irritability or poor sleep. Use only if clearly necessary and at the lowest effective dose.
• Pediatrics: Not recommended for children; the fixed-dose combination is formulated for adults.
• Elderly: Use with caution — greater sensitivity to phenylephrine's cardiovascular effects and to caffeine.
• Hepatic impairment: Reduce dose or avoid; risk of paracetamol hepatotoxicity.
• Renal impairment: Use with caution; dose adjustment may be needed in severe impairment.

19. Storage Conditions

• Store at a temperature not exceeding 30 °C.
• Keep in the original packaging, protected from light and moisture.
• Keep out of the reach and sight of children.
• Do not use after the expiration date printed on the pack.

20. Additional Sections

• Legal status (Egypt): Over-the-counter (OTC) cold and flu preparation.
• Pack size: Box of 2 strips × 10 tablets (20 tablets).
• Indicative retail price (Egyptian market): approximately 24.00 EGP per pack (subject to change by the Egyptian Drug Authority and retailer).
• Overdose management: Suspected paracetamol overdose is a medical emergency even in asymptomatic patients — seek immediate hospital care; N-acetylcysteine is the specific antidote. Excess phenylephrine may cause hypertension, headache, reflex bradycardia, and arrhythmia; caffeine overdose may cause tremor, tachycardia, agitation, and seizures.
• Driving and operating machinery: Unlikely to impair, but individual sensitivity to caffeine or dizziness should be considered.
• Environmental disposal: Do not dispose of medicines in wastewater or household waste; return unused medication to the pharmacy.

21. Frequently Asked Questions (FAQ)

Q1. Can I take Ezamol-C with another paracetamol-containing product?
No. Combining products that contain paracetamol increases the risk of accidental overdose and liver injury. Keep the total paracetamol dose ≤ 4 g/day in adults.

Q2. How quickly does it start working?
Paracetamol usually begins to reduce pain and fever within 30–60 minutes; nasal decongestion and general symptomatic relief develop over the same time frame.

Q3. Can I drink coffee or energy drinks while taking Ezamol-C?
Limit additional caffeine. Each tablet contains 25 mg of caffeine, so 8 tablets/day add up to about 200 mg; combined with dietary caffeine, this may cause palpitations, insomnia, or anxiety.

Q4. Is Ezamol-C safe in pregnancy or breastfeeding?
Do not use it without consulting a doctor. Paracetamol alone is preferred if an analgesic-antipyretic is required.

Q5. Can I take it with blood pressure medication?
Consult your doctor. Phenylephrine may raise blood pressure and reduce the effect of some antihypertensives.

Q6. Can it be given to children?
The tablet is intended for adults. Do not use in children unless a physician specifically advises it.

Q7. What should I do if I miss a dose?
Take it when needed for symptom relief; do not double a dose to make up for a missed one, and respect the maximum of 4 doses/24 hours.

Q8. How long can I take it?
For short-term symptomatic relief only. If symptoms persist for more than a few days, or worsen, consult a healthcare professional.

22. References

1. Egyptian Drug Authority (EDA) — Product monograph and public price index for Ezamol-C.
2. Multi-Apex for Pharmaceutical Industries S.A.E. — Manufacturer product information.
3. Drugs.com — Paracetamol (acetaminophen), phenylephrine, caffeine, ascorbic acid monographs.
4. MedlinePlus (U.S. National Library of Medicine) — Consumer drug information: acetaminophen; phenylephrine; caffeine; vitamin C.
5. Martindale: The Complete Drug Reference — Paracetamol, phenylephrine, caffeine, terpin hydrate, ascorbic acid.
6. British National Formulary (BNF) — Analgesics and cold preparations.
7. U.S. FDA (2024) — Proposed order to remove oral phenylephrine from the OTC nasal decongestant monograph (efficacy-based).
8. Health Canada — Safety review of the acetaminophen–phenylephrine interaction.
9. Edinoff AN et al. Clinically Relevant Drug Interactions with Monoamine Oxidase Inhibitors. 2022.
10. WHO Model Formulary — Symptomatic treatment of upper respiratory tract infections.