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
Pain reliever/fever reducer Nasal decongestant
temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever
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.
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.
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
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
● 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.
Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution. Questions or comments? call 1-855-274-4122 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2022 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in India Code: TS/DRUGS/22/2009
♥CVS Health™ Compare to the active ingredients in Advil ® Cold &Sinus** Non-Drowsy NDC 69842-092-67 Cold & Sinus Relief IBUPROFEN, USP 200 mg - Pain reliever, Fever reducer (NSAID) PSEUDOEPHEDRINE HCI, USP 30 mg - Nasal decongestant IBUPROFEN & PSEUDOEPHEDRINE HCI CAPSULES Relieves: • Sinus pressure • Nasal congestion & Fever 20 LIQUID-FILLED CAPSULES (2 X 10 CAPSULES PER BLISTER CARD) Actual Size
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-092-13 | Ibuprofen and Pseudoephedrine HCl | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | 4 | |
| 69842-092-13 | Ibuprofen and Pseudoephedrine HCl | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 4 | |
| 69842-092-67 | Ibuprofen and Pseudoephedrine HCl | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 4 | |
| 69842-092-67 | Ibuprofen and Pseudoephedrine HCl | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69842-092-67 | EA - Each | 69842-092 | 2290b24a-6df7-4b81-a9fc-9f56613c2372 | 1 | 2021-05-05 |
| Product NDC | Package NDC |
|---|---|
| 69842-092 | 69842-092-67, 69842-092-13 |
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
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
Pain reliever/fever reducer Nasal decongestant
temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever
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.
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.
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
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
take with food or milk if stomach upset occurs
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
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
● 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.
Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution. Questions or comments? call 1-855-274-4122 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2022 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in India Code: TS/DRUGS/22/2009
♥CVS Health™ Compare to the active ingredients in Advil ® Cold &Sinus** Non-Drowsy NDC 69842-092-67 Cold & Sinus Relief IBUPROFEN, USP 200 mg - Pain reliever, Fever reducer (NSAID) PSEUDOEPHEDRINE HCI, USP 30 mg - Nasal decongestant IBUPROFEN & PSEUDOEPHEDRINE HCI CAPSULES Relieves: • Sinus pressure • Nasal congestion & Fever 20 LIQUID-FILLED CAPSULES (2 X 10 CAPSULES PER BLISTER CARD) Actual Size