The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Services, Inc. for the product Ibuprofen 200mg (NDC 69822-693). 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 directions, warnings, inactive ingredients, uses, keep out of reach of children., purposes, active ingredient (in each tablet), don not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Adults and children 12 years and older:
Children under 12 years: ask a doctor
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 chances are higher if you
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
Temporarily relieves minor aches and pains due to:
In case of overdose, get medical help or contact a Poison Control Center right away
Pain reliever/fever reducer
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory dru
you experience any of the following signs of stomach bleeding:
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.
* Please review the disclaimer below.
