FDA Label for Ibuprofen
View Indications, Usage & Precautions
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Geri-care Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Brown Tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
- Temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- headache
- Temporarily reduces fever
Warnings
Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- shock
- hives
- facial swelling
- asthma (wheezing)
- skin reddening
- rash
- blisters
- 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: 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. - if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- the 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
- 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
- take with food or milk if stomach upset occurs
- 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 - leg swelling
- slurred speech - weakness in one part or side of body - pain gets worse or lasts more than 10 days
- redness or swelling is present in the painful area
- fever gets worse or lasts more than 3 days
- any new symptoms occur
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:
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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
Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not use 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 take more than 6 tablets in 24 hours unless directed by a doctor
- children under 12 years: ask a doctor
Other Information
- store at controlled room temperature
- avoid excessive heat 40°C (104°F)
Inactive Ingredients
carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.
Questions Or Comments?
Call 1-800-540-3765
Package Label
GERICARE
NDC 57896-941-01
IBUPROFEN
pain reliever/fever reducer (NSAID)
COMPARE TO THE ACTIVE INGREDIENT IN ADVIL*
100 Tablets
200 mg each
Tamper Evident:
Do not use if imprinted seal under cap is missing or broken.
* Please review the disclaimer below.