Drugplain

Fast Pain Relief 200 mg/1

Ibuprofen · TABLET, COATED · HealthLife of USA LLC

1 Recall on Record
Plain English

Fast Pain Relief is a tablet, coated containing ibuprofen at 200 mg/1, taken oral. Manufactured by HealthLife of USA LLC.

Key Facts

Brand Name
Fast Pain Relief
Generic Name
Ibuprofen
NDC Code (Product)
69517-111
Manufacturer
HealthLife of USA LLC
Strength
200 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
ANDA079174
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
01/01/2011

Recall History

1 Recall on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective15,485 reports
pain14,872 reports
fatigue14,243 reports
nausea13,254 reports
headache11,918 reports
arthralgia10,746 reports
dyspnoea10,356 reports
vomiting9,803 reports
diarrhoea9,540 reports
rash8,898 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses 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

Directions: do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets 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 Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma you are taking a

Frequently Asked Questions

What is Fast Pain Relief used for?

Fast Pain Relief contains Ibuprofen. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Fast Pain Relief a controlled substance?

Fast Pain Relief is not classified as a controlled substance by the DEA.

What is the generic name for Fast Pain Relief?

The generic name for Fast Pain Relief is Ibuprofen. There are 12 other brand versions of Ibuprofen.

What is the NDC code for Fast Pain Relief 200 mg/1?

The NDC (National Drug Code) for Fast Pain Relief 200 mg/1 is 69517-111, listed by HealthLife of USA LLC.