PROF COLD&FLU TAB

Indications

Approved Uses

Temporary relief of common cold/flu symptoms including nasal congestion, runny nose/rhinorrhea, sneezing, headache, fever, and minor aches and pains (may also relieve sinus pressure/pain associated with congestion).

Dosage & Administration

Dosing by Condition

Adults and children ≥12 years: 1 tablet every 4-6 hours as needed; do not exceed 6 tablets in 24 hours; not recommended for <12 years unless directed by a clinician.

Children's Dosage

Not recommended for children under 12 years of age.

Dose Adjustment Notes

No routine dose adjustment for short-term OTC use, but use the lowest effective dose for the shortest duration; avoid in severe renal impairment and use caution in renal/hepatic impairment and in older adults; do not use longer than label-directed duration without medical advice.

How to Take

Swallow the film‑coated tablet whole with water; do not crush or chew. May be taken with food or milk if stomach upset occurs.

Side Effects

Common Side Effects

Drowsiness/sedation, dizziness, dry mouth, nausea/dyspepsia or upset stomach, constipation, blurred vision; nervousness/insomnia and palpitations may occur; urinary retention/hesitancy can occur (especially in BPH).

Safety & Warnings

Contraindications

Hypersensitivity to ibuprofen/other NSAIDs (including aspirin-exacerbated respiratory disease) or to pseudoephedrine or chlorpheniramine; concomitant use of MAOIs or within 14 days; third trimester of pregnancy; active peptic ulcer/GI bleeding; severe hypertension or significant coronary artery disease; narrow-angle glaucoma; urinary retention/prostatic hypertrophy; severe renal impairment (eGFR/CrCl <30 mL/min); avoid peri-operative use in CABG surgery; not for children <12 years.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; avoid duplicate NSAID/ibuprofen-containing products; caution in hypertension/heart disease, diabetes, thyroid disease, glaucoma, and BPH/urinary retention; may cause drowsiness-avoid driving/alcohol/sedatives; pseudoephedrine may raise BP/HR; stop and seek care for GI bleeding, chest pain/neurologic symptoms, severe rash, or allergic reaction.

Age Restriction

Not for use in children under 12 years (unless specifically directed by a clinician).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major/clinically important interactions include: MAOIs (contraindicated-hypertensive crisis with pseudoephedrine); other NSAIDs/aspirin (additive GI/renal risk); anticoagulants/antiplatelets (increased bleeding with ibuprofen); SSRIs/SNRIs (increased GI bleeding risk); antihypertensives/diuretics/ACEi/ARBs (reduced BP control and increased renal risk with NSAIDs); lithium and methotrexate (increased levels/toxicity with NSAIDs); sedatives/alcohol (additive CNS depression with chlorpheniramine); tricyclic antidepressants/other sympathomimetics (enhanced pressor/CNS effects with pseudoephedrine).

Interaction Severity

MAJOR/CONTRAINDICATED: MAO inhibitors within 14 days (risk of hypertensive crisis with pseudoephedrine). MAJOR: Concomitant anticoagulants/antiplatelets (e.g., warfarin) and other NSAIDs (including ketorolac) due to increased bleeding/GI toxicity. MODERATE: Antihypertensives/diuretics/ACEi/ARBs (reduced BP control and renal risk), SSRIs/SNRIs (increased GI bleeding risk with NSAID), lithium and methotrexate (increased levels/toxicity), tricyclic antidepressants/other sympathomimetics (enhanced pressor/CNS effects), alcohol/CNS depressants (additive sedation with chlorpheniramine).

Food Interaction

Food is not required, but taking with food or milk can reduce ibuprofen-related stomach upset.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Ibuprofen: Category C (1st/2nd trimester); D (3rd trimester); Pseudoephedrine: Category C; Chlorpheniramine: Category B

Breastfeeding

Consult Doctor

Children

Not recommended for children under 12 years of age.

Elderly

Use lowest effective dose for shortest duration; increased risk of GI bleeding, renal impairment, and cardiovascular events; monitor blood pressure and renal function; chlorpheniramine may cause excessive sedation and anticholinergic effects in elderly patients

Kidney Impairment

Mild-to-moderate renal impairment (eGFR/CrCl 30-60 mL/min): use with caution, lowest effective dose/shortest duration; severe impairment (eGFR/CrCl <30 mL/min): avoid.

Liver Impairment

Mild-to-moderate hepatic impairment: use with caution at the lowest effective dose for the shortest duration; severe hepatic impairment: avoid.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose.

Stopping the Medicine

May be stopped at any time when symptoms resolve; no taper is required for short-term OTC use.

Overdose

Overdose may cause GI symptoms (nausea/vomiting/epigastric pain), CNS effects (drowsiness, dizziness, agitation, seizures), tinnitus, and cardiovascular effects (hypertension, tachycardia/arrhythmias) and urinary retention; seek emergency care/poison center immediately-management is supportive (consider activated charcoal if early, monitor vitals, ECG, renal function).

Patient Counseling

Swallow whole with water; take with food/milk if stomach upset. Adults/≥12 years: 1 tablet every 4-6 hours as needed; max 6 tablets/24 h. May cause drowsiness-avoid driving/alcohol and other sedatives. Do not combine with other NSAIDs/ibuprofen-containing products or other decongestants/antihistamines. Seek advice before use if you have hypertension/heart disease, thyroid disease, glaucoma, prostate enlargement/urinary retention, or kidney disease; stop and seek care for chest pain, severe dizziness, shortness of breath, black/tarry stools, vomiting blood, or severe rash. Avoid in pregnancy especially 3rd trimester unless advised by a clinician.

Monitoring Requirements

No routine monitoring for short-term OTC use; consider monitoring blood pressure/heart rate in patients with hypertension/CVD and watch for GI bleeding symptoms and renal risk in susceptible patients.

Pharmacology

Mechanism of Action

Ibuprofen inhibits COX-1/COX-2 to reduce prostaglandin synthesis (analgesic/antipyretic/anti-inflammatory); pseudoephedrine is a sympathomimetic (primarily alpha-adrenergic) causing nasal vasoconstriction; chlorpheniramine is a first-generation H1 receptor antagonist reducing histamine-mediated symptoms (rhinorrhea/sneezing/itching).

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours.

Bioavailability

Ibuprofen: ~80% (rapid absorption). Pseudoephedrine: high oral bioavailability (often cited ~90% or higher). Chlorpheniramine: variable, ~25-50%.

Excretion

Ibuprofen: primarily renal excretion of metabolites (minimal unchanged). Pseudoephedrine: renal excretion with a substantial fraction unchanged (pH-dependent). Chlorpheniramine: primarily renal excretion (as metabolites and some unchanged).

Protein Binding

Ibuprofen: >99% protein bound; Pseudoephedrine: low protein binding (approximately 0-20%); Chlorpheniramine: ~70% protein bound (commonly reported ~69-72%).

Product Information

Available Dosage Forms

Film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: Ibuprofen 200mg + Pseudoephedrine hydrochloride 30mg + Chlorpheniramine maleate 2mg

OTC Alternatives

Symptom-targeted OTC options: paracetamol (acetaminophen) for pain/fever; ibuprofen alone for pain/fever; pseudoephedrine or topical nasal decongestant for congestion; non-sedating antihistamine (e.g., loratadine/cetirizine) for prominent allergic symptoms; avoid duplicating ingredients with other combination cold/flu products.

Symptom Target

Multi-symptom

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 08-06-2026