Label: ADVIL ALLERGY SINUS- chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl tablet, coated
- NDC Code(s): 0573-0188-10
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 20, 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:
- 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
- you have a breathing problem such as emphysema or chronic bronchitis
- 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, glaucoma, 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 sedatives or tranquilizers
- taking any other product that contains pseudoephedrine, chlorpheniramine or any other nasal decongestant or antihistamine
- 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
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
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
- redness or swelling is present in the painful area
- you get nervous, dizzy, or sleepless
- symptoms continue or get worse
- any new symptoms appear
- Directions
- Other information
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Inactive ingredients
carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glyceryl behenate, hypromellose, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, titanium dioxide
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- Additional Information
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PRINCIPAL DISPLAY PANEL
Advil
ALLERGY SINUS
Ibuprofen 200 mg ➤ Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg ➤ Nasal Decongestant
Chlorpheniramine Maleate 2 mg ➤ AntihistamineRelieves Runny Nose, Nasal Congestion, Sneezing,
Itchy, Watery Eyes, Headache and Sinus PressureONLY
1
PILL
EVERY
4-6
HOURSAdvil
A/S20 COATED CAPLETS*
*Capsule-Shaped Tablets
PAA148681 Carton
-
INGREDIENTS AND APPEARANCE
ADVIL ALLERGY SINUS
chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0188 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg 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 CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C RED NO. 40 (UNII: WZB9127XOA) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color orange (bright orange) Score no score Shape OVAL (oval shaped tablet) Size 15mm Flavor Imprint Code Advil;A;S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0188-10 20 in 1 CARTON 12/20/2002 1 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 NDA021441 12/20/2002 Labeler - Haleon US Holdings LLC (079944263)