PROPRINAL — Capsule, Liquid Filled

Overview

Brand name

PROPRINAL

Generic name

Ibuprofen Capsules 200 mg

Dosage form

Capsule, Liquid Filled

Route

Oral

Marketing category

ANDA · ANDA

Labeler

A-S Medication Solutions

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

6

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

8

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

079205

Application type

ANDA · Abbreviated New Drug Application

Approval date

June 26, 2009

Sponsor

MARKSANS PHARMA

Products on application

1

Submissions recorded

5

Products approved under application 079205.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
079205-001	IBUPROFEN	CAPSULE		IBUPROFEN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 079205.
Type	No.	Action	Status	Date	Review
Supplement	11	Labeling	Approved	May 5, 2023	Standard
Supplement	5	Labeling	Approved	May 5, 2023	Standard
Supplement	4	Labeling	Approved	April 10, 2015	—
Supplement	2	Labeling	Approved	July 31, 2013	—
Original application	1		Approved	June 26, 2009	—

Review documents

0 · Original application · September 19, 2011

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241204). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241204 HUMAN OTC DRUG · 20240129

Indications and Usage

openFDA Drug Labeling

Uses: Temporarily relieves minor aches and pains due to: headache muscular aches backache minor arthritis pain the common cold toothache menstrual cramps Temporarily reduces fever

Purpose

openFDA Drug Labeling

Purpose Pain reliever/Fever reducer

Dosage and Administration

openFDA Drug Labeling

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 take more than 6 capsules in 24 hours, unless directed by a doctor children under 12 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 blisters shock facial swelling asthma (wheezing) rash skin reddening 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.

Do Not Use

openFDA Drug Labeling

Do not use if you have ever had an allergic reaction to any pain reliever/fever reducer right before or after heart surgery

Ask a Doctor

openFDA Drug Labeling

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, asthma, or had a stroke you are taking a diuretic

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if an allergic reaction occurs, seek medical help right away fever worsens or lasts more than 3 days pain worsens or lasts more than 10 days you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better new symptoms occur redness or swelling is present you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling

Active Ingredient

openFDA Drug Labeling

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

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-3507 NDC: 50090-3507-0 2 CAPSULE, LIQUID FILLED in a PACKET / 300 in a BOX

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
50090-3507-0	50090-3507	A-S Medication Solutions	300 PACKET in 1 BOX (50090-3507-0) / 2 CAPSULE, LIQUID FILLED in 1 PACKET	July 18, 2018
50332-0130-1	50332-0130	HART Health	300 PACKET in 1 BOX (50332-0130-1) / 2 CAPSULE, LIQUID FILLED in 1 PACKET	January 11, 2017
50332-0130-3	50332-0130	HART Health	20 PACKET in 1 BAG (50332-0130-3) / 2 CAPSULE, LIQUID FILLED in 1 PACKET	January 11, 2017
50332-0130-4	50332-0130	HART Health	40 PACKET in 1 BOX (50332-0130-4) / 2 CAPSULE, LIQUID FILLED in 1 PACKET	January 11, 2017
50332-0130-7	50332-0130	HART Health	100 PACKET in 1 BOX (50332-0130-7) / 2 CAPSULE, LIQUID FILLED in 1 PACKET	January 11, 2017
50332-0130-8	50332-0130	HART Health	200 PACKET in 1 BOX (50332-0130-8) / 2 CAPSULE, LIQUID FILLED in 1 PACKET	January 11, 2017
50090-3507	50090-3507	A-S Medication Solutions	—	January 11, 2017
50332-0130	50332-0130	HART Health	—	January 11, 2017

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 · 10 sections on this page.