Label: ADVIL COLD AND SINUS- ibuprofen and pseudoephedrine hydrochloride capsule, liquid filled
- NDC Code(s): 0573-0184-16, 0573-0184-32
- Packager: Pfizer Consumer Healthcare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- DRUG FACTS
- ACTIVE INGREDIENTS (IN EACH LIQUID-FILLED CAPSULE)
- sinus pressure
- nasal congestion
- minor body aches and pains
- facial swelling
- asthma (wheezing)
- skin reddening
Stomach bleeding warning:
- 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
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 or trouble urinating due to an enlarged prostate gland
- 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
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- 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.
- 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 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRODUCT PACKAGING
- INGREDIENTS AND APPEARANCE
ADVIL COLD AND SINUS
ibuprofen, pseudoephedrine hcl capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0184 Route of Administration ORAL DEA Schedule 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) coconut acid (UNII: 40U37V505D) gelatin (UNII: 2G86QN327L) polyethylene glycols (UNII: 3WJQ0SDW1A) potassium hydroxide (UNII: WZH3C48M4T) sorbitan (UNII: 6O92ICV9RU) sorbitol (UNII: 506T60A25R) water (UNII: 059QF0KO0R) Product Characteristics Color ORANGE (light orange to light yellow with a slight orange hue) Score no score Shape OVAL (oval softgel) Size 15mm Flavor Imprint Code Advil;C;S;with;black;ink Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0184-32 1 in 1 CARTON 1 32 in 1 BLISTER PACK 2 NDC:0573-0184-16 2 in 1 CARTON 2 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021374 05/30/2002 Labeler - Pfizer Consumer Healthcare (828831730)