Label: ADVIL COLD AND SINUS- ibuprofen, pseudoephedrine hydrochloride capsule, liquid filled
- NDC Code(s): 0573-0184-16, 0573-0184-32
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 26, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each liquid-filled capsule)
- Purposes
- Uses
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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:
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- have 3 or more alcoholic drinks every day while using this product
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- 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
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- in children under 12 years of age
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
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- 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
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- stomach bleeding warning applies to you
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have a history of stomach problems, such as heartburn
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- 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
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- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
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- under a doctor's care for any serious condition
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- taking any other product that contains pseudoephedrine or any other nasal decongestant
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- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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- taking any other drug
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- you have symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- fever gets worse or lasts more than 3 days
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- nasal congestion lasts for more than 7 days
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- symptoms continue or get worse
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- redness or swelling is present in the painful area
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- you get nervous, dizzy, or sleepless
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- any new symptoms appear
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Directions
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- do not take more than directed
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- the smallest effective dose should be used
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- adults and children 12 years of age and over:
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- take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
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- do not use more than 6 capsules in any 24-hour period unless directed by a doctor
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- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions or comments?
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Additional Information
READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION
Product inside sealed in plastic blister with foil backing.
Do Not Use if plastic blister or foil barrier is broken.For most recent product information,
visit www.advil.comDistributed by: GSK Consumer Healthcare, Warren, NJ 07059
Trademarks owned or licensed by GSK ©2021 GSK or licensor
LIQUI-GELS® is a trademark or registered trademark of Catalent Pharma Solutions.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVIL COLD AND SINUS
ibuprofen, pseudoephedrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0184 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color ORANGE Score no score Shape OVAL Size 15mm Flavor Imprint Code Advil;C;S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0184-32 32 in 1 CARTON 05/30/2002 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0573-0184-16 16 in 1 CARTON 05/30/2002 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021374 05/30/2002 Labeler - Haleon US Holdings LLC (079944263)
