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Ibuprofen and Pseudoephedrine Hydrochloride
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 |
|---|---|---|---|---|---|---|---|
| 074567-001 | IBUPROHM COLD AND SINUS | TABLET | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | Discontinued | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 29 | Labeling | Approved | January 9, 2012 | — |
| Supplement | 28 | Labeling | Approved | January 9, 2012 | — |
| Supplement | 27 | Labeling | Approved | January 9, 2012 | — |
| Supplement | 26 | Labeling | Approved | August 18, 2008 | — |
| Supplement | 23 | Labeling | Approved | September 27, 2006 | — |
| Supplement | 20 | Labeling | Approved | March 22, 2006 | — |
| Supplement | 17 | Labeling | Approved | July 19, 2004 | — |
| Supplement | 9 | Labeling | Approved | August 13, 2002 | — |
| Supplement | 8 | Labeling | Approved | July 17, 2002 | — |
| Supplement | 7 | Manufacturing (CMC) | Approved | July 17, 2002 | — |
| Supplement | 6 | Manufacturing (CMC) | Approved | July 17, 2002 | — |
| Supplement | 5 | Manufacturing (CMC) | Approved | May 17, 2002 | — |
| Supplement | 4 | Manufacturing (CMC) | Approved | May 17, 2002 | — |
| Supplement | 3 | Manufacturing (CMC) | Approved | January 31, 2002 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | January 28, 2002 | — |
| Supplement | 2 | Labeling | Approved | August 29, 2001 | — |
| Original application | 1 | Approved | April 17, 2001 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260731). 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 fever sinus pressure nasal congestion minor body aches and pains
Purpose
openFDA Drug LabelingActive ingredients (in each caplet) Purposes Ibuprofen, USP 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Pseudoephedrine HCl, USP 30 mg 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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use Other information store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40oC (104oF). 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 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 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 Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other product that contains pseudoephedrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 LabelingActive ingredients (in each caplet) Purposes Ibuprofen, USP 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Pseudoephedrine HCl, USP 30 mg Nasal decongestant
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 |
|---|---|---|---|---|
| 58602-839-13 | 58602-839 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-839-13) / 8 TABLET, COATED in 1 BLISTER PACK | March 10, 2023 |
| 10158-065-01 | 10158-065 | Haleon US Holdings LLC | 500000 TABLET, COATED in 1 DRUM (10158-065-01) | September 19, 1989 |
| 11822-0084-5 | 11822-0084 | Rite-Aid | 1 BLISTER PACK in 1 CARTON (11822-0084-5) / 20 TABLET, COATED in 1 BLISTER PACK | February 1, 2018 |
| 58602-839 | 58602-839 | Aurohealth LLC | — | March 10, 2023 |
| 10158-065 | 10158-065 | Haleon US Holdings LLC | — | September 19, 1989 |
| 11822-0084 | 11822-0084 | Rite-Aid | — | February 1, 2018 |
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 · 11 sections on this page.