FDA records indicate that there are no current recalls for this drug.
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Advil Congestion Relief Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
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
- in children under 12 years of age because this product contains too much medication for children under this 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.
- 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
- under a doctor's care for any serious condition
- taking any other product that contains phenylephrine or any other nasal decongestant
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
- 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
- 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
- pain gets worse or lasts more than 7 days
- 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.
- in children under 12 years of age because this product contains too much medication for children under this 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.
- 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
- under a doctor's care for any serious condition
- taking any other product that contains phenylephrine or any other nasal decongestant
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
- 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
- pain gets worse or lasts more than 7 days
- 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
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves these symptoms associated with the common cold or flu:
- headache
- fever
- sinus pressure
- nasal congestion
- minor body aches and pains
- reduces swelling of the nasal passages
- temporarily restores freer breathing through the nose
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Advil Congestion Relief Manufacturers
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Lil’ Drug Store Products, Inc
Advil Congestion Relief | Lil' Drug Store Products, Inc
do not take more than directed adults and children 12 years of age and over: take 1 tablet every 4 hours while symptoms persist do not use more than 6 tablets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use because this product contains too much medication for children under this age -
Pfizer Consumer Healthcare
Advil Congestion Relief | Upsher-smith Laboratories, Inc.
2.1 Congestive Heart Failure Post-Myocardial InfarctionTreatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone tablets may be administered with or without food.
Once treatment with eplerenone tablets has begun, adjust the dose based on the serum potassium level as shown in Table 1.
Table 1: Dose Adjustment in Congestive Heart Failure Post-MISerum
Potassium
(mEq/L)
Action
Dose Adjustment
<5
Increase
25 mg every other day to 25 mg once daily
25 mg once daily to 50 mg once daily
5 to 5.4
Maintain
No adjustment
5.5 to 5.9
Decrease
50 mg once daily to 25 mg once daily
25 mg once daily to 25 mg every other day
25 mg every other day to withhold
≥ 6
Withhold
Restart at 25 mg every other day when potassium levels fall to <5.5 mEq/L
2.2 HypertensionThe recommended starting dose of eplerenone tablets is 50 mg administered once daily. The full therapeutic effect of eplerenone tablets is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone tablets should be increased to 50 mg twice daily. Higher dosages of eplerenone tablets are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia [see CLINICAL STUDIES (14.2)].
2.3 Recommended MonitoringSerum potassium should be measured before initiating eplerenone tablet therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate [see WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2)]. In the EPHESUS study [see CLINICAL STUDIES (14.1)], the majority of hyperkalemia was observed within the first three months after randomization.
In all patients taking eplerenone tablets who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3 to 7 days.
2.4 Dose Modifications for Specific PopulationsFor hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil, and fluconazole), the starting dose of eplerenone tablets should be reduced to 25 mg once daily [see DRUG INTERACTIONS (7.1)].
No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment [see CLINICAL PHARMACOLOGY (12.3)].
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