Active Ingredient
Ibuprofen 200 mg (NSAID)1
1 - nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Pain Reliever / Fever Reducer (NDC 72090-002). 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, purpose, uses:, warnings:, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 200 mg (NSAID)1
1 - 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
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
you have symptoms of heart problems or stroke:
If pregnant or breast-feeding, 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Pregelatinized Starch, Maize Starch, Sodium Starch Glycolate, Povidone K-30, Purified Water, Stearic Acid, Colloidal Silicon Dioxide, Opadry II 85F565026
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Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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