FDA Label for Good Neighbor Pharmacy Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- 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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS {CARTON CONFIGURATION ONLY}
- DIRECTIONS {NON-CRC BOTTLE CONFIGURATION ONLY}
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Good Neighbor Pharmacy Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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 Tablet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
• temporarily relieves minor aches and pains due to:• headache• muscular aches• minor pain of arthritis• toothache• backache• the common cold• menstrual cramps• temporarily reduces fever
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• 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
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 chances are higher if you
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
• you have problems or serious side effects from taking pain relievers or fever reducers• the stomach bleeding warning applies to you• you have a history of stomach problems, such as heartburn• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease• you have asthma• you are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
• taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin• under a doctor’s care for any serious condition• 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 Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions {Carton Configuration Only}
• do not take more than directed• the smallest effective dose should be used• 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• ask a doctor
adults and children 12 years and older | |
children under 12 years |
Directions {Non-Crc Bottle Configuration Only}
• do not take more than directed• the smallest effective dose should be used• 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
Adults and children 12 years and older:
Children under 12 years: ask a doctor
Other Information
• read all warnings and directions before use• store at 20-25°C (68-77°F)• avoid high humidity and excessive heat above 40°C (104°F)• see end panel for lot number and expiration date {For Carton Configuration Only}
Inactive Ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Compare to Advil® active ingredient
Ibuprofen tablets 200 mg
Pain Reliever/Fever Reducer (NSAID)
See New Warnings Information
500 + 50 FREE = 550 tablets
200 mg each
actual size
* Please review the disclaimer below.