IBUPROFEN
REMEDYREPACK INC.
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
OTC - ACTIVE INGREDIENT
OTC - PURPOSE
OTC - WHEN USING
-
● temporarily relieves minor aches and pains due to:
-
● minor pain of arthritis
-
● temporarily reduces fever
WARNINGS
Allergy alert:
Stomach bleeding warning:
-
● have had stomach ulcers or bleeding problems
-
● take a blood thinning (anticoagulant) or steroid drug
-
● take other drugs containing perscription or nonperscription 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
OTC - DO NOT USE
-
● if you have ever had an allergic reaction to any other pain reliever/fever reducer
-
● right before or after heart surgery
OTC - ASK DOCTOR
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
STOP USE AND ASK DOCTOR IF
-
● have bloody or black stools
-
● have stomach pain that does not get better
IF PREGNANT OR BREAST FEEDING
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
WARNINGS
-
● 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
OTHER INFORMATION
-
● store at controlled room temperature
-
● avoid excessive heat above 40(104
-
● use by expiration date on package
INACTIVE INGREDIENT
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
IBUPROFEN
IBUPROFEN TABLET
Product Information
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:49349-123(NDC:16103-0395-99) |
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
|
orange |
13 mm |
IP;143 |
ROUND |
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
NDC:49349-123-02 |
30 in 1 BLISTER PACK |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
ANDA |
ANDA075659 |
2010-12-08 |
|
|
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!