Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: North Safety Products LLC
NDC Code: 0498-7500
temporarily relieves minor aches and pains due to:
headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis
temporarily reduces fever
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 if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery
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, or asthma 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 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 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive Ingredients: Corn Starch, DC yellow 10, FDC Blue 1, Microcrystalline Cellulose, Povidone, stearic acid
Pain Reliever, Fever Reducer
Active Ingredient (in each tablet): Ibuprofen 200 mg
do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
|Labeler - North Safety Products LLC (059980441)|
|Registrant - North Safety Products LLC (059980441)|
|ULTRAtab Laboratories, Inc.||151051757||manufacture|
|Ultra Seal Corporation||085752004||repack|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.