SDA Laboratories, Inc.
Pharbest Pharmaceuticals, Inc.
Drug Facts
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Active Ingredient (In each tablet)
Purpose
Ibuprofen Uses
- minor pain of arthritis
- headache
- toothache
- backache
- the common cold
- menstrual cramps
- muscular aches
- temporarily reduces fever
Warnings
- 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 non prescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks everyday 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 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 last for more than 10 days
- fever gets worse or last 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
This package is not for households with young children.
Directions
-
do not take more than directed
-
the smallest effective dose should be used
Adults and children 12 years and older
|
- take 1 tablet every4 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
|
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other information
- store between 20o- 25oC (68o- 77oF)
- avoid high humidity and excessive heat above 40oC (104oF)
Inactive Ingredients:
Questions? Adverse drug event call: (800)687-0176
®
Ibuprofen
Ibuprofen TABLET
Product Information
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Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:66424-996 |
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
|
brown |
9 mm |
2I |
ROUND |
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
NDC:66424-996-10 |
1000 in 1 BOTTLE, PLASTIC |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
ANDA |
ANDA075661 |
2011-01-27 |
|
|