Drugplain

Motrin IB 200 mg/1

Ibuprofen · TABLET, FILM COATED · Morning Star OTC

1 Recall on Record
Plain English

Motrin IB is a tablet, film coated containing ibuprofen at 200 mg/1, taken oral. Manufactured by Morning Star OTC.

Key Facts

Brand Name
Motrin IB
Generic Name
Ibuprofen
NDC Code (Product)
53209-2001
Manufacturer
Morning Star OTC
Strength
200 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA077349
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
06/19/2025

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 ineffective15,837 reports
pain14,988 reports
fatigue14,395 reports
nausea13,413 reports
headache12,031 reports
arthralgia10,811 reports
dyspnoea10,461 reports
vomiting9,889 reports
diarrhoea9,697 reports
rash8,968 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use treats migraine

Dosage & Administration

Directions do not take more than directed the smallest effective dose should be used adults take 2 capsules with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 capsules in 24 hours, unless directed by a doctor under 18 years of age 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. Medication overuse headache warning Headaches may worsen if this product is used for 10 or more days per month. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after hear

Frequently Asked Questions

What is Motrin IB used for?

Motrin IB contains Ibuprofen. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Motrin IB a controlled substance?

Motrin IB is not classified as a controlled substance by the DEA.

What is the generic name for Motrin IB?

The generic name for Motrin IB is Ibuprofen. There are 12 other brand versions of Ibuprofen.

What is the NDC code for Motrin IB 200 mg/1?

The NDC (National Drug Code) for Motrin IB 200 mg/1 is 53209-2001, listed by Morning Star OTC.