Drugplain

Ibuprofen (NSAID) Pain Releiver/ Fever Reducer 200 mg/1

Ibuprofen · TABLET · Amneal Pharmaceuticals of New York LLC

No Recall History
Plain English

Ibuprofen (NSAID) Pain Releiver/ Fever Reducer is a tablet containing ibuprofen at 200 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.

Key Facts

Brand Name
Ibuprofen (NSAID) Pain Releiver/ Fever Reducer
Generic Name
Ibuprofen
NDC Code (Product)
53746-144
Manufacturer
Amneal Pharmaceuticals of New York LLC
Strength
200 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA072199
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
12/16/2009

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective15,477 reports
pain14,869 reports
fatigue14,244 reports
nausea13,254 reports
headache11,918 reports
arthralgia10,747 reports
dyspnoea10,352 reports
vomiting9,802 reports
diarrhoea9,538 reports
rash8,899 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses 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 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor Children under 12 years ask a doctor

Warnings

Warnings Allergy alert: Ibuprofen 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 nonprescription 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 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 if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain

Frequently Asked Questions

What is Ibuprofen (NSAID) Pain Releiver/ Fever Reducer used for?

Ibuprofen (NSAID) Pain Releiver/ Fever Reducer contains Ibuprofen. It is a tablet taken oral. Consult your doctor for specific uses.

Is Ibuprofen (NSAID) Pain Releiver/ Fever Reducer a controlled substance?

Ibuprofen (NSAID) Pain Releiver/ Fever Reducer is not classified as a controlled substance by the DEA.

What is the generic name for Ibuprofen (NSAID) Pain Releiver/ Fever Reducer?

The generic name for Ibuprofen (NSAID) Pain Releiver/ Fever Reducer is Ibuprofen. There are 12 other brand versions of Ibuprofen.

What is the NDC code for Ibuprofen (NSAID) Pain Releiver/ Fever Reducer 200 mg/1?

The NDC (National Drug Code) for Ibuprofen (NSAID) Pain Releiver/ Fever Reducer 200 mg/1 is 53746-144, listed by Amneal Pharmaceuticals of New York LLC.