Active Ingredient(S)
Ibuprofen 200 mg (NSAID)*
· nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium Llc for the product Ibuprofen (NDC 68016-295). 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 active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 200 mg (NSAID)*
· nonsteroidal anti-inflammatory drug
Pain reliever / fever reducer
Allergy alerts: Ibuprofen may cause a severe allergy 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:
you have
you are
These are 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 a problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a PoisonControlCenter right away.
| adults and children 12 years and older |
|
| Children under 12 years |
|
Colloidal silicon dioxide, Croscarmellose Sodium, Magnesium stearate, Microcrystalline sodium, Pregelatinised starch, talc.
Carton Label PDP
NDC# 68016-295-01
DYE FREE
Ibuprofen Tablets 200 mg
PAIN RELIEVER/FEVER REDUCER (NSAID)
SEE NEW WARNINGS INFORMATION
100 COATED TABLETS
Bottle Label PDP
NDC# 68016-295-01
DYE FREE
Ibuprofen Tablets 200 mg
PAIN RELIEVER/FEVER REDUCER (NSAID)
SEE NEW WARNINGS INFORMATION
100 COATED TABLETS
Carton Label PDP
NDC# 68016-295-50
DYE FREE
Ibuprofen Tablets 200 mg
PAIN RELIEVER/FEVER REDUCER (NSAID)
SEE NEW WARNINGS INFORMATION
50 COATED TABLETS
Bottle Label PDP
NDC# 68016-295-50
DYE FREE
Ibuprofen Tablets 200 mg
PAIN RELIEVER/FEVER REDUCER (NSAID)
SEE NEW WARNINGS INFORMATION
50 COATED TABLETS
* Please review the disclaimer below.