On this page
Ibuprofen and Pseudoephedrine HCl
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever
Purpose
openFDA Drug LabelingPurposes Pain reliever/fever reducer Nasal decongestant
Dosage and Administration
openFDA Drug LabelingDirections ● 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingDrug 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 FAERSAttributed 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| 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
| 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.