Label: ADVIL COLD AND SINUS- ibuprofen and pseudoephedrine hydrochloride tablet, coated
- NDC Code(s): 0573-0180-10, 0573-0180-21
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 31, 2024
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- ACTIVE INGREDIENTS (IN EACH CAPLET)
- 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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
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- do not use more than 6 caplets 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
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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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVIL COLD AND SINUS
ibuprofen and pseudoephedrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0180 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 DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) METHYLPARABEN (UNII: A2I8C7HI9T) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN (butterscotch) Score no score Shape OVAL (oblong) Size 14mm Flavor Imprint Code Advil;Cold;Sinus Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0180-10 2 in 1 CARTON 09/19/1989 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0573-0180-21 4 in 1 CARTON 09/19/1989 2 10 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 NDA019771 09/19/1989 Labeler - Haleon US Holdings LLC (079944263) Establishment Name Address ID/FEI Business Operations PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC 118346012 ANALYSIS(0573-0180) , MANUFACTURE(0573-0180)
