Cardinal Health Congestion Relief Drug Facts
Drug Labeling and Warnings
Drug Details [pdf]
LEADER CONGESTION RELIEF- ibuprofen, phenylephrine hcl tablet, film coated
Cardinal Health
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Cardinal Health Congestion Relief Drug Facts
Active ingredients (in each tablet)
Ibuprofen 200 mg (NSAID)*
Phenylephrine HCl 10 mg
*nonsteroidal anti-inflammatory 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
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 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
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 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
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
- 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. (1-800-222-1222)
Directions
- 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
Other information
- store at 20-25°C (68-77°). Avoid excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
Compare to Advil® Congestion Relief active ingredients
Congestion Relief
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine Hydrochloride 10 mg Nasal Decongestant, Tablets
CONTAINS: Ibuprofen & Phenylephrine
NON-DROWSY relief of: Sinus Pressure, Nasal Swelling & Congestion, and Headache
1 Pill Dosage
Actual Size
10 COATED TABLETS
| LEADER CONGESTION RELIEF
ibuprofen, phenylephrine hcl tablet, film coated |
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| Labeler - Cardinal Health (097537435) |
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