Drugplain

Ibuprofen Pain Reliever/Fever Reducer 200 mg/1

Ibuprofen · CAPSULE, LIQUID FILLED · Amneal Pharmaceuticals LLC

No Recall History
Plain English

Ibuprofen Pain Reliever/Fever Reducer is a capsule, liquid filled containing ibuprofen at 200 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.

Key Facts

Brand Name
Ibuprofen Pain Reliever/Fever Reducer
Generic Name
Ibuprofen
NDC Code (Product)
65162-770
Manufacturer
Amneal Pharmaceuticals LLC
Strength
200 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
ANDA202300
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
12/23/2011

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective15,479 reports
pain14,874 reports
fatigue14,244 reports
nausea13,252 reports
headache11,914 reports
arthralgia10,747 reports
dyspnoea10,350 reports
vomiting9,802 reports
diarrhoea9,540 reports
rash8,900 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Dosage & Administration

DOSAGE AND ADMINISTRATION DIRECTIONS do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used. do not exceed 6 capsules 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 a nonsteroidal anti-inflammatory drug (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

Frequently Asked Questions

What is Ibuprofen Pain Reliever/Fever Reducer used for?

Ibuprofen Pain Reliever/Fever Reducer contains Ibuprofen. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Ibuprofen Pain Reliever/Fever Reducer a controlled substance?

Ibuprofen Pain Reliever/Fever Reducer is not classified as a controlled substance by the DEA.

What is the generic name for Ibuprofen Pain Reliever/Fever Reducer?

The generic name for Ibuprofen Pain Reliever/Fever Reducer is Ibuprofen. There are 12 other brand versions of Ibuprofen.

What is the NDC code for Ibuprofen Pain Reliever/Fever Reducer 200 mg/1?

The NDC (National Drug Code) for Ibuprofen Pain Reliever/Fever Reducer 200 mg/1 is 65162-770, listed by Amneal Pharmaceuticals LLC.