PL Developments
PL Developments
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Active ingredient (in each capsule)
Purpose
Pain reliever/ fever reducer
Ibuprofen 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:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
Stomach bleeding warning:
- 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 non prescription NSAIDS [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for 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
- 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
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 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
Keep out of reach of children
Directions
-
do not take more than directed
-
the smallest effective dose should be used
- adults and children 12 years and over:
- take 1 capsule every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 capsule, 2 capsules may be used
- do not exceed 6 capsules in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Ibuprofen Other information
-
each capsule contains: potassium 20 mg
- read all warnings and directions before use.
- store at 20°- 25°C (68°- 77°F)
- avoid excessive heat above 40°C (104°F). Protect from light.
Inactive ingredients
Questions or comments?
1-877-753-3935
Ibuprofen
Ibuprofen CAPSULE, LIQUID FILLED
Product Information
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:59726-120 |
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
Ingredient Name
|
Basis of Strength
|
Strength
|
IBUPROFEN IBUPROFEN |
|
200 mg
|
Product Characteristics
|
Color
|
Size
|
Imprint Code
|
Shape
|
blue |
10 mm |
IB200 |
CAPSULE |
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
|
2 in 1 POUCH |
|
|
2 |
NDC:59726-120-04 |
2 in 1 CARTON |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
ANDA |
ANDA078682 |
2012-05-17 |
|
|