Active ingredientIbuprofen, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Indications and 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
Dosage and administration
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
Storage and handling
store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep card.
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
WARNINGS SECTION
Allergy alert
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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, have 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
OTC - ASK DOCTOR/PHARMACIST SECTION
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
OTC - WHEN USING SECTION
take with food or milk if stomach upset occurs
Stop use and ask a doctor if
OTC - STOP USE SECTION
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
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
read all warnings and directions before use. Keep card.
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