Drugplain

IBUPROFEN 200 MG 200 mg/1

IBUPROFEN 200 MG · TABLET, COATED · Farmacias De Similares TX LLC

5 Recalls on Record
Plain English

IBUPROFEN 200 MG is a tablet, coated containing ibuprofen 200 mg at 200 mg/1, taken oral. Manufactured by Farmacias De Similares TX LLC.

Key Facts

Brand Name
IBUPROFEN 200 MG
Generic Name
IBUPROFEN 200 MG
NDC Code (Product)
85786-107
Manufacturer
Farmacias De Similares TX LLC
Strength
200 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
ANDA079174
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
01/01/2026

Recall History

5 Recalls on Record
Class II03/16/2020

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

TerminatedVoluntary: Firm initiated
Class II03/16/2020

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

TerminatedVoluntary: Firm initiated
Class II01/25/2018

PD-Rx Pharmaceuticals, Inc.

CGMP deviations.

TerminatedVoluntary: Firm initiated
Class III02/26/2014

Pfizer Us Pharmaceutical Group

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

TerminatedVoluntary: Firm initiated
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 ineffective15,481 reports
pain14,879 reports
fatigue14,254 reports
nausea13,257 reports
headache11,923 reports
arthralgia10,752 reports
dyspnoea10,361 reports
vomiting9,814 reports
diarrhoea9,544 reports
rash8,902 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 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 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 warming: 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. 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

Frequently Asked Questions

What is IBUPROFEN 200 MG used for?

IBUPROFEN 200 MG contains IBUPROFEN 200 MG. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is IBUPROFEN 200 MG a controlled substance?

IBUPROFEN 200 MG is not classified as a controlled substance by the DEA.

What is the generic name for IBUPROFEN 200 MG?

The generic name for IBUPROFEN 200 MG is IBUPROFEN 200 MG. There are 2 other brand versions of IBUPROFEN 200 MG.

What is the NDC code for IBUPROFEN 200 MG 200 mg/1?

The NDC (National Drug Code) for IBUPROFEN 200 MG 200 mg/1 is 85786-107, listed by Farmacias De Similares TX LLC.

Product NDC

85786-107

Package NDC

85786-107-30

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)