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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Ibuwin Forte (NDC 69729-157). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet/caplet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Ibuprofen 200 mg (NSAID) *
nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning
This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you:
Heart attack and stroke warning
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away.
| adults and children 12 years and older |
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| children under 12 years |
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colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide, triacetin
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
* Please review the disclaimer below.