Drug Facts
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Ibuprofen, Solubilized (NDC 66715-5646). 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 drug facts, active ingredient, purpose, uses, warnings, allergy alert, stomach bleeding warning, heart attack and stroke warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredient (in each capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
Warnings
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.
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
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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.
Directions
Other information
Inactive ingredients
FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
Questions or comments?
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Ibuprofen
Solubilized Ibuprofen Capsules,
200 mg
Pain Reliever/Fever Reducer
(NSAID)
compare to
ADVIL
® LIQUI-GELS
®
active ingredient**
20
LIQUID-FILLED
CAPSULES
Actual Size
[liquid-filled capsule image]
* Please review the disclaimer below.