Quick answers
- What is Ibuprofen and pseudoephedrine used for?
- The Drug Facts label of Advil Cold and Sinus (Haleon US Holdings LLC) lists these uses: temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains.
- Do I need a prescription for Ibuprofen and pseudoephedrine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Ibuprofen and pseudoephedrine been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Advil Cold and Sinus · Haleon US Holdings LLC
Ibuprofen 200 mg · Pseudoephedrine hydrochloride 30 mg, capsule, liquid filled (oral)
Active ingredient (in each liquid-filled capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) Pseudoephedrine HCl 30 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer Nasal decongestant
Uses
temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
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 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 at 20 weeks or later in 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.
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
Inactive ingredients
D&C yellow no. 10, FD&C red no. 40, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution
Questions?
Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL
— FDA label of Advil Cold and Sinus, Haleon US Holdings LLC, effective July 29, 2026. See the official label on DailyMed →
Advil Cold and Sinus · Haleon US Holdings LLC
Ibuprofen 200 mg · Pseudoephedrine hydrochloride 30 mg, tablet, coated (oral)
Active ingredient (IN EACH CAPLET)
Ibuprofen 200 mg (NSAID)* Pseudoephedrine HCl 30 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer Nasal decongestant
Uses
temporarily relieves these symptoms associated with the common cold or flu:
- headache
- fever
- sinus pressure
- nasal congestion
- minor body aches and pains
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 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.
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 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
Inactive ingredients
acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide
Questions?
Call toll free 1-800-88-ADVIL
— FDA label of Advil Cold and Sinus, Haleon US Holdings LLC, effective June 13, 2025. See the official label on DailyMed →
Ibuprofen and Pseudoephedrine Hydrochloride · Publix Super Markets Inc
Ibuprofen 200 mg · Pseudoephedrine hydrochloride 30 mg, tablet, sugar coated (oral)
Active ingredient (in each caplet)
Purposes Ibuprofen, USP 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Pseudoephedrine HCl, USP 30 mg Nasal decongestant
Purpose
Active 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
Uses
temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
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 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)
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 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
Inactive ingredients
acacia, calcium carbonate, carnauba wax, confectioner's sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax
— FDA label of Ibuprofen and Pseudoephedrine Hydrochloride, Publix Super Markets Inc, effective July 31, 2026. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Ibuprofen 200 mg · Pseudoephedrine hydrochloride 30 mg · capsule, liquid filled (oral) · 6 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Advil Cold and Sinus | Haleon US Holdings LLC | DailyMed |
| Cold and Sinus Relief | Cardinal Health 110, LLC. DBA Leader | — |
| Ibuprofen and Pseudoephedrine HCl | Amerisource Bergen | DailyMed |
| Ibuprofen and Pseudoephedrine HCl | Aurohealth LLC | DailyMed |
| Ibuprofen and Pseudoephedrine HCl | CVS Pharmacy, Inc. | DailyMed |
| Ibuprofen and Pseudoephedrine HCl | Walgreen Co. | DailyMed |
Ibuprofen 200 mg · Pseudoephedrine hydrochloride 30 mg · tablet, coated (oral) · 4 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Advil Cold and Sinus | Haleon US Holdings LLC | DailyMed |
| Ibuprofen and Pseudoephedrine Hydrochloride | Aurohealth LLC | DailyMed |
| Ibuprofen and Pseudoephedrine Hydrochloride | Rite-Aid | DailyMed |
Ibuprofen 200 mg · Pseudoephedrine hydrochloride 30 mg · tablet, sugar coated (oral) · 3 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Ibuprofen and Pseudoephedrine hydrochloride | Ohm Laboratories Inc. | DailyMed |
| Ibuprofen and Pseudoephedrine Hydrochloride | Publix Super Markets Inc | DailyMed |
| Ibuprofen and Pseudoephedrine Hydrochloride | Strategic Sourcing Services LLC | DailyMed |
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Haleon US Holdings LLC3 products
- Aurohealth LLC2 products
- Amerisource Bergen1 product
- CVS Pharmacy, Inc.1 product
- Rite-Aid1 product
- Cardinal Health 110, LLC. DBA Leader1 product
- Walgreen Co.1 product
- Ohm Laboratories Inc.1 product
- Strategic Sourcing Services LLC1 product
- Publix Super Markets Inc1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.