PROF 400/MG FC TAB 30/FC TAB

Indications

Approved Uses

Symptomatic relief of mild to moderate pain and fever; and anti‑inflammatory use in conditions such as dysmenorrhea and rheumatic disorders (e.g., osteoarthritis, rheumatoid arthritis) when used under medical advice.

Dosage & Administration

Dosing by Condition

Adults/≥12 years (OTC): 200-400 mg every 4-6 hours as needed; maximum 1,200 mg/day without medical supervision. Dysmenorrhea: 400 mg every 4-6 hours as needed (do not exceed 1,200 mg/day OTC). Inflammatory arthritis (OA/RA, prescription/medical supervision): 1,200-3,200 mg/day in 3-4 divided doses (maximum 3,200 mg/day).

Initial Dose

400mg as a single dose

Maintenance Dose

400mg every 4-6 hours as needed

Maximum Dose

OTC maximum: 1200 mg/day. Prescription maximum: up to 3200 mg/day in divided doses (under medical supervision).

Children's Dosage

Adults and children 12 years and older: adult dosing applies. This 400mg tablet formulation is not suitable for young children

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; in older adults start at the low end and monitor closely; avoid in severe renal impairment and use caution (consider dose reduction) in mild-moderate renal impairment; use caution in hepatic impairment.

How to Take

Swallow the 400 mg film‑coated tablet whole with a full glass of water; take with food or milk to reduce gastrointestinal irritation; do not crush or chew.

Side Effects

Common Side Effects

Dyspepsia/indigestion, heartburn, nausea (± vomiting), abdominal pain, diarrhea or constipation, flatulence/bloating, dizziness, headache.

Side Effect Frequency

Common (1-10%): dyspepsia/heartburn, nausea, abdominal pain, diarrhea, constipation, flatulence/bloating, headache, dizziness, rash. Uncommon (<1%): GI ulceration and GI bleeding/perforation, renal impairment/abnormal renal function, tinnitus, hypersensitivity reactions (including anaphylaxis) and severe cutaneous adverse reactions (rare).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to ibuprofen or other NSAIDs; history of asthma/urticaria/allergic-type reactions after aspirin/NSAIDs (AERD); peri-operative pain in CABG surgery. Avoid/contraindicated per many labels in: active GI bleeding/peptic ulcer; third-trimester pregnancy.

Warnings & Precautions

Key warnings/precautions: increased risk of CV thrombotic events; serious GI bleeding/ulceration/perforation (may occur without warning); use caution in hypertension, heart failure/edema, renal impairment, hepatic impairment, and history of GI disease; avoid in third trimester of pregnancy; monitor BP/renal function in at-risk patients and discontinue if signs of serious skin reaction or hepatic dysfunction occur.

Drug Interactions

Drug Interactions

Clinically important interactions include: anticoagulants (e.g., warfarin) and antiplatelets (incl. aspirin) ↑ bleeding; other NSAIDs ↑ toxicity; ACE inhibitors/ARBs and diuretics ↑ renal risk/↓ antihypertensive/diuretic effect; lithium ↑ levels; methotrexate ↑ toxicity; corticosteroids and SSRIs/SNRIs ↑ GI bleeding; cyclosporine/tacrolimus ↑ nephrotoxicity.

Interaction Severity

MAJOR/clinically significant: anticoagulants/antiplatelets (e.g., warfarin) ↑ bleeding; concomitant other NSAIDs ↑ GI/renal toxicity; lithium ↑ lithium levels/toxicity; methotrexate (especially high-dose) ↑ toxicity; systemic corticosteroids and SSRIs/SNRIs ↑ GI bleeding risk. MODERATE: ACE inhibitors/ARBs and diuretics ("triple whammy") ↑ renal impairment and may blunt antihypertensive/diuretic effect; cyclosporine/tacrolimus ↑ nephrotoxicity. SPECIAL: aspirin-ibuprofen may reduce aspirin’s antiplatelet effect if taken concomitantly (separate dosing if needed).

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Avoid after 29 weeks; earlier use with caution/discuss with provider

Children

Adults and children 12 years and older: adult dosing applies. This 400mg tablet formulation is not suitable for young children

Elderly

Use lowest effective dose for shortest duration. Increased risk of GI bleeding, renal impairment, and cardiovascular events. Monitor renal function and blood pressure regularly.

Liver Impairment

Mild-moderate hepatic impairment: use with caution at the lowest effective dose; severe hepatic impairment/severe active liver disease: avoid (often treated as contraindicated in practice).

Storage & Patient Advice

Overdose

Overdose may cause nausea/vomiting/abdominal pain, dizziness/drowsiness, headache/tinnitus; severe toxicity can include metabolic acidosis, seizures, coma, hypotension, acute kidney injury, and respiratory depression. Management: urgent medical evaluation/poison center, consider activated charcoal if early and appropriate, and provide supportive care with monitoring (renal function, electrolytes, acid-base status).

Patient Counseling

Take with food or milk and a full glass of water; use the lowest effective dose for the shortest time; do not exceed 1,200 mg/day OTC and do not use >10 days for pain or >3 days for fever without medical advice; avoid combining with other NSAIDs and limit alcohol; seek care for black/tarry stools, vomiting blood, severe abdominal pain, chest pain/shortness of breath, or facial swelling; avoid in the 3rd trimester of pregnancy and consult a clinician if you have ulcer/bleeding history, kidney disease, heart disease, uncontrolled hypertension, or are on anticoagulants/antiplatelets.

Monitoring Requirements

Short-term OTC use: no routine lab monitoring. Long-term/high-dose use or high-risk patients: monitor blood pressure, renal function (SCr/eGFR), CBC (for anemia/bleeding), and liver enzymes periodically; assess for GI bleeding symptoms.

Pharmacology

Mechanism of Action

Reversibly and nonselectively inhibits COX‑1 and COX‑2, decreasing prostaglandin synthesis, which reduces pain, fever, and inflammation.

Duration of Effect

4-6 hours

Product Information

Available Dosage Forms

For this product: film‑coated tablet (oral), 400 mg, blister pack of 30 tablets.

Composition per Dose

Each film-coated tablet: 400mg ibuprofen

Generic Availability

Yes

Pain Type

General, Muscular, Joint

Nsaid

Yes

Opioid

No

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