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Ibuprofen and Pseudoephedrine HCl

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ibuprofen and Pseudoephedrine HCl
Generic name
Ibuprofen and Pseudoephedrine HCl
Dosage form
Capsule, Liquid Filled
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Amerisource Bergen
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
6
Packages
12
Data completeness
82% 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
Pseudoephedrine Hydrochloride 30 mg/1 1305603 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Liquid Filled
Route of administration
Oral
Presentations
18

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
Adrenergic alpha-Agonists [MoA] MoA All 85 members
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
alpha-Adrenergic Agonist [EPC] EPC All 85 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
209235
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 1, 2017
Sponsor
AUROBINDO PHARMA
Products on application
1
Submissions recorded
1
Products approved under application 209235.
Product Trade name Form Strength Ingredient Status TE Flags
209235-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 209235.
Type No. Action Status Date Review
Original application 1 Approved December 1, 2017 Standard

Review documents

  • 0 · Original application · January 8, 2018

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260616). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260616 HUMAN OTC DRUG · 20230714

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever

Purposes Pain reliever/fever reducer Nasal decongestant

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 of age and over: ● take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used. ● do not use more than 6 capsules in any 24-hour period unless directed by a doctor ● children under 12 years of age: do not use Other information each capsule contains: potassium 20 mg store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep carton.

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.

Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke you are taking a diuretic

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 fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredients (in each liquid-filled capsule) Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)* (present as the free acid and potassium salt) Pseudoephedrine Hydrochloride USP 30 mg *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
46122-609-58 46122-609 Amerisource Bergen 4 BLISTER PACK in 1 CARTON (46122-609-58) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 1, 2017
59651-640-82 59651-640 Aurobindo Pharma Limited 800 CAPSULE, LIQUID FILLED in 1 BAG (59651-640-82) April 27, 2021
58602-803-03 58602-803 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-803-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) January 17, 2020
58602-803-08 58602-803 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-803-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) December 1, 2017
58602-803-13 58602-803 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-803-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-79) December 1, 2017
58602-803-67 58602-803 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-803-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) December 1, 2017
70000-0606-1 70000-0606 CARDINAL HEALTH 110, LLC. DBA LEADER 2 BLISTER PACK in 1 CARTON (70000-0606-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK May 7, 2022
70000-0606-2 70000-0606 CARDINAL HEALTH 110, LLC. DBA LEADER 4 BLISTER PACK in 1 CARTON (70000-0606-2) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK June 16, 2026
69842-092-13 69842-092 CVS Pharmacy, Inc. 4 BLISTER PACK in 1 CARTON (69842-092-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 1, 2017
69842-092-67 69842-092 CVS Pharmacy, Inc. 2 BLISTER PACK in 1 CARTON (69842-092-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 1, 2017
0363-1106-08 0363-1106 WALGREEN CO. 4 BLISTER PACK in 1 CARTON (0363-1106-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 1, 2017
0363-1106-67 0363-1106 WALGREEN CO. 2 BLISTER PACK in 1 CARTON (0363-1106-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 1, 2017
46122-609 46122-609 Amerisource Bergen — December 1, 2017
59651-640 59651-640 Aurobindo Pharma Limited — April 27, 2021
58602-803 58602-803 Aurohealth LLC — December 1, 2017
70000-0606 70000-0606 CARDINAL HEALTH 110, LLC. DBA LEADER — May 7, 2022
69842-092 69842-092 CVS Pharmacy, Inc. — December 1, 2017
0363-1106 0363-1106 WALGREEN CO. — December 1, 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.