ibuprofen, pseudoephedrine hydrochloride
Dosage Form: tablet, coated
Advil Cold & Sinus Caplets
(ibuprofen and pseudoephedrine HCl)
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH CAPLET)
*nonsteroidal anti-inflammatory drug
PURPOSES
USES
temporarily relieves these symptoms associated with the common cold or flu:
- headache
- fever
- sinus pressure
- nasal congestion
- minor body aches and pains
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
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 have 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years of age and over:
- take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
- do not use more than 6 caplets in any 24-hour period unless directed by a doctor
- children under 12 years of age: do not use
OTHER INFORMATION
- 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
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
QUESTIONS OR COMMENTS?
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Ibuprofen 200 mg >> Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg >> Nasal Decongestant
Relieves Sinus Pressure, Nasal Congestion and Fever
Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth
For most recent product information, visit www.advil.com
Appearance of the tan Advil Cold & Sinus caplet is a trademark of Wyeth Consumer Healthcare
Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019771 | 09/19/1989 | |
| Labeler - Pfizer Consumer Healthcare (828831730) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Wyeth Pharmaceuticals Company, Consumer Site | 829390975 | MANUFACTURE, ANALYSIS | |
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