Active Ingredients (In Each Capsule)
Solubilized Ibuprofen equal to 200 mg ibuprofen (NSAID)*
(Present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Strides Pharma Inc for the product Ibuprofen (NDC 59556-764). 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 ingredients (in each capsule), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Solubilized Ibuprofen equal to 200 mg ibuprofen (NSAID)*
(Present as the free acid and potassium salt)
*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.
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 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.
FD&C blue 1, gelatin, gelatin (hydrolyzed), medium chain triglyceride, PEG 600, potassium hydroxide, sorbital and sorbitan solution. Printing ink: white edible oil, propylene glycol, shellac resins, sodium lauryl sulphate, isopropyl alcohol, titanium dioxide.
Call toll free number 1-877-244-9825
Code No.: KR/DRUGS/KTK/25/415/98
For most recent product information, visit us at www.stridesshasun.com
Revised: 08/2017
Manufactured by:
Strides Shasun Limited
Bengaluru – 560076, India.
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
* Please review the disclaimer below.