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EXTRA STRENGTH IBUPROFEN LIQUID is a brand name for Ibuprofen, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IBPUPROFEN LIQUID CAPSULES and EXTRA STRENGTH IBUPROFEN LIQUID CAPSULES (Ibuprofen Capsules) are indicated for: • headache pain including tension headache; • relief of minor aches and pains in muscles, bones and joints, body pain, backache, muscle sprains and strains; • pain from inflammation associated with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Do not take for fever for more than 3 days or for pain for more than 5 days unless directed by a physician. 4 Geriatrics). 2 Recommended Dose and Dosage Adjustment Ibuprofen Liquid Capsules: Adults and children over 12: Take 1 (every 4 hours) or 2 (every 6 to 8 hours) capsules as needed.
Do not exceed 6 capsules in 24 hours, unless directed by a physician.
Extra Strength Ibuprofen Liquid Capsules Adults and children over 12:
Take 1 capsule every 6 to 8 hours as needed. Do not exceed 3 capsules in 24 hours, unless directed by a physician. 2 Recommended Dose and Dosage Adjustment. 4 Missed Dose Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip your missed dose.
Do not take two doses at the same time.
1 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 2 Post-Market Adverse Reactions Prescription Experience The following adverse reactions have been noted in patients treated with prescription doses (≥1200 mg/day).
Note:
Reactions listed below under Causal Relationship Unknown are those which occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility of a relationship to ibuprofen cannot be excluded.
IBUPROFEN LIQUID CAPSULES (Ibuprofen Capsules) EXTRA STRENGTH IBUPROFEN LIQUID CAPSULES (Ibuprofen Capsules) Page 15 of 44 Gastrointestinal The adverse reactions most frequently seen with prescribed ibuprofen therapy involve the gastrointestinal system.
Incidence 3 to 9%: nausea, epigastric pain, heartburn. Incidence 1 to 3%: diarrhoea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of the gastrointestinal tract (bloating or flatulence).
Incidence less than 1%: gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal haemorrhage, melena, hepatitis, jaundice, abnormal liver function (SGOT, serum bilirubin and alkaline phosphatase). Allergic Incidence less than 1%: anaphylaxis (see 2 CONTRAINDICATIONS).
Causal relationship unknown: fever, serum sickness, lupus erythematosus. Central Nervous System Incidence 3 to 9%: dizziness. Incidence 1 to 3%: headache, nervousness. Incidence less than 1%: depression, insomnia. Causal relationship unknown: paresthesias, hallucinations, dream abnormalities.
1 Special Populations 05/2026 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 14 8 ADVERSE REACTIONS ................................................................................................
14 9 DRUG INTERACTIONS ................................................................................................ 21 10 CLINICAL PHARMACOLOGY .......................................................................................
22 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 24 PART II: SCIENTIFIC INFORMATION .......................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Aseptic meningitis and meningoencephalitis, in one case accompanied by eosinophilia in the cerebrospinal fluid, have been reported in patients who took ibuprofen intermittently and did not have any connective tissue disease. Dermatologic Incidence 3 to 9%: rash (including maculopapular type).
Incidence 1 to 3%: pruritus. Incidence less than 1%: vesiculobullous eruptions, urticaria, erythema multiforme. Causal relationship unknown: alopecia, Stevens-Johnson syndrome. Cardiovascular Incidence less than 1%: congestive heart failure in patients with marginal cardiac function, elevated blood pressure.
Causal relationship unknown: arrhythmias (sinus tachycardia, sinus bradycardia, palpitations). Special Senses IBUPROFEN LIQUID CAPSULES (Ibuprofen Capsules) EXTRA STRENGTH IBUPROFEN LIQUID CAPSULES (Ibuprofen Capsules) Page 16 of 44 Incidence 1 to 3%: tinnitus.
Incidence less than 1%: amblyopia (blurred and/or diminished vision, scotomata and/or changes in colour vision). Any patient with eye complaints during ibuprofen therapy should have an ophthalmological examination. Causal relationship unknown: conjunctivitis, diplopia, optic neuritis.
Hematologic Incidence less than 1%: leukopenia and decreases in haemoglobin and hematocrit. , purpura, epistaxis, hematuria, menorrhagia). Renal Causal relationship unknown: decreased creatinine clearance, polyuria, azotemia. Like other non-steroidal anti-inflammatory drugs, ibuprofen inhibits renal prostaglandin synthesis, which may decrease renal function and cause sodium retention.
Renal blood flow and glomerular filtration rate decreased in patients with mild impairment of renal function who took 1200 mg/day of ibuprofen for one week. Renal papillary necrosis has been reported. A number of factors appear to increase the risk of renal toxicity (see 7 WARNINGS AND PRECAUTIONS).
Hepatic Incidence less than 1%: hepatitis, jaundice, abnormal liver function (SGOT, serum bilirubin, and alkaline phosphatase). Endocrine Causal relationship unknown: gynecomastia, hypoglycaemic reaction. , for three days before menses.
Metabolic Incidence 1 to 3%: decreased appetite, oedema, fluid retention. Fluid retention generally responds promptly to drug discontinuation (see 7 WARNINGS AND PRECAUTIONS).
Non-Prescription Experience:
Literature (1992-1999) (at dosages ≤1200 mg/day) One researcher conducted an extensive analysis of published data concerning the relative safety of non-prescription doses of ibuprofen and acetaminophen. Of a total of 96 randomized and blinded trials, there were 10 trials of seven days’ duration or less where the safety of both drugs was directly compared.
In three of these trials, the incidence of adverse events was higher with acetaminophen; there were no reported adverse events in six trials; and one trial reported a higher incidence with ibuprofen. In this subset of 10 studies, it was reported that gastrointestinal adverse events were found to be the most common type of event reported and were predominantly dyspepsia, nausea, or IBUPROFEN LIQUID CAPSULES (Ibuprofen Capsules) EXTRA STRENGTH IBUPROFEN LIQUID CAPSULES (Ibuprofen Capsules) Page 17 of 44 vomiting.
None of the GI events appeared to warrant follow-up from which the author inferred there were no serious gastrointestinal events. ” A double-blind, placebo-controlled study (N=1246) was conducted to prospectively evaluate the gastrointestinal tolerability, as compared to placebo, of the […]
25 13 PHARMACEUTICAL INFORMATION ............................................................................ 25 14 CLINICAL TRIALS ........................................................................................................
28 15 MICROBIOLOGY ........................................................................................................ 30 16 NON-CLINICAL TOXICOLOGY .....................................................................................
30 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 32 PATIENT MEDICATION INFORMATION .................................................................................. 33 PATIENT MEDICATION INFORMATION ..................................................................................
39 IBUPROFEN LIQUID CAPSULES (Ibuprofen Capsules) EXTRA STRENGTH IBUPROFEN LIQUID CAPSULES (Ibuprofen […]