Drugplain

Ibuprofen Immediate Release 200 mg/1

Ibuprofen · TABLET, COATED · Strides Pharma Inc.

No Recall History
Plain English

Ibuprofen Immediate Release is a tablet, coated containing ibuprofen at 200 mg/1, taken oral. Manufactured by Strides Pharma Inc..

Key Facts

Brand Name
Ibuprofen Immediate Release
Generic Name
Ibuprofen
NDC Code (Product)
59556-856
Manufacturer
Strides Pharma Inc.
Strength
200 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
ANDA091355
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
04/04/2011

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective15,478 reports
pain14,872 reports
fatigue14,245 reports
nausea13,252 reports
headache11,914 reports
arthralgia10,747 reports
dyspnoea10,354 reports
vomiting9,798 reports
diarrhoea9,539 reports
rash8,899 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE(S) temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Dosage & Administration

DIRECTIONS do not take more than directed the smallest effective dose should be used adults and children 12 years and older take 1 tablet or caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used do not exceed 6 tablets or caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor OTHER INFORMATION store between 20°-25°C (68° - 77°F) do not use if imprinted text "SEALED FOR YOUR PROTECTION" on the safety seal under cap is broken or missing Sodium free Each tablet contains 0.714 mg of Magnesium see end panel for lot number and expiration date.

Warnings

WARNINGS Allergy alert: Ibuprofen USP may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters 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: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart failure, and stroke. these can be fatal. The risk is higher if you use more than directed or for longer than directed.

Frequently Asked Questions

What is Ibuprofen Immediate Release used for?

Ibuprofen Immediate Release contains Ibuprofen. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Ibuprofen Immediate Release a controlled substance?

Ibuprofen Immediate Release is not classified as a controlled substance by the DEA.

What is the generic name for Ibuprofen Immediate Release?

The generic name for Ibuprofen Immediate Release is Ibuprofen. There are 12 other brand versions of Ibuprofen.

What is the NDC code for Ibuprofen Immediate Release 200 mg/1?

The NDC (National Drug Code) for Ibuprofen Immediate Release 200 mg/1 is 59556-856, listed by Strides Pharma Inc..