Migraine Relief — Capsule, Liquid Filled

Overview

Brand name

Migraine Relief

Generic name

Ibuprofen

Dosage form

Capsule, Liquid Filled

Route

Oral

Marketing category

ANDA · ANDA

Labeler

WALGREENS

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

4

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Ibuprofen	200 mg/1	310965	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Capsule, Liquid Filled

Route of administration

Oral

Presentations

6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Anti-Inflammatory Agents	EPC	All 251 members
Cyclooxygenase Inhibitors [MoA]	MoA	All 251 members
Non-Steroidal [CS]	CS	All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC]	EPC	All 251 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

078682

Application type

ANDA · Abbreviated New Drug Application

Approval date

March 24, 2009

Sponsor

BIONPHARMA

Products on application

1

Submissions recorded

7

Products approved under application 078682.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
078682-001	IBUPROFEN	CAPSULE		IBUPROFEN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 078682.
Type	No.	Action	Status	Date	Review
Supplement	20	Manufacturing (CMC)	Approved	November 12, 2019	Unknown
Supplement	21	Labeling	Approved	February 21, 2019	Standard
Supplement	16	Labeling	Approved	February 21, 2019	Standard
Supplement	12	Labeling	Approved	July 31, 2013	Standard
Supplement	3	Labeling	Approved	March 12, 2013	—
Supplement	7	Manufacturing (CMC)	Approved	April 27, 2012	—
Original application	1		Approved	March 24, 2009	—

Review documents

0 · Supplement · January 7, 2021
0 · Supplement · January 7, 2021
0 · Supplement · January 7, 2021
0 · Original application · September 19, 2011
0 · Original application · April 14, 2009

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20221228). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20221228

Indications and Usage

openFDA Drug Labeling

Uses treats migraine

Purpose

openFDA Drug Labeling

Purpose Pain reliever

Dosage and Administration

openFDA Drug Labeling

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

openFDA Drug Labeling

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 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

openFDA Drug Labeling

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

openFDA Drug Labeling

Ask a doctor before use if you have never had migraines diagnosed by a health professional you have a headache that is different from your usual migraines you have the worst headache of your life you have fever and stiff neck you have headaches beginning after or caused by head injury, exertion, coughing or bending you have experienced your first headache after the age of 50 you have daily headaches you have a migraine so severe as to require bed rest 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, asthma, or had a stroke you are taking a diuretic

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling migraine headache pain is not relieved or gets worse after the first dose any new symptoms appear

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each orange oval capsule) Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS

283,546

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
69452-263-11	69452-263	Bionpharma Inc.	1 BOTTLE in 1 CARTON (69452-263-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE	May 1, 2019
69452-263-78	69452-263	Bionpharma Inc.	1 BOTTLE in 1 CARTON (69452-263-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE	May 1, 2019
69452-263-79	69452-263	Bionpharma Inc.	160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-263-79)	February 1, 2021
0363-0240-78	0363-0240	WALGREENS	1 BOTTLE in 1 CARTON (0363-0240-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE	March 13, 2019
69452-263	69452-263	Bionpharma Inc.	—	May 1, 2019
0363-0240	0363-0240	WALGREENS	—	March 13, 2019

Related products

same generic name, other forms

Migraine Relief Tablet migraine relief Tablet, Film Coated

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.