IBUPROFEN tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
13-07-2023

Aktiv ingrediens:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Tilgjengelig fra:

Preferred Pharmaceuticals, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Produkt oppsummering:

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Repackaged by Preferred Pharmaceuticals, Inc.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

                                Preferred Pharmaceuticals, Inc.
----------
IBUPROFEN TABLETS
400 MG - 600 MG- 800 MG MEDGUIDE
Revised: 7/2023
Document Id: eae45ecc-731a-418e-8a94-cef595fb83c3
34391-3
Set id: 20fda75a-c560-428b-b9fd-c12e97df4a74
Version: 4
Effective Time: 20230713
Preferred Pharmaceuticals, Inc.
                                
                                read_full_document
                                
                            

Preparatomtale

                                IBUPROFEN- IBUPROFEN TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
----------
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS
IBUPROFEN TABLETS
400 MG - 600 MG- 800 MG MEDGUIDE
HOW SUPPLIED
400mg (white to of white, round, biconvex, film coated tablets
debossed with '121' on
one side and plain on the other side)
REPACKAGED BY PREFERRED PHARMACEUTICALS, INC.
400MG IBUPROFEN
Bottles of 20 NDC 68788-7745-02
Bottles of 28 NDC 68788-7745-08
Bottles of 30 NDC 68788-7745-03
Bottles of 50 NDC 68788-7745-05
Bottles of 60 NDC 68788-7745-06
Bottles of 90 NDC 68788-7745-09
Bottles of 100 NDC 68788-7745-01
IBUPROFEN
ibuprofen tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION
DRUG
ITEM CODE
(SOURCE)
NDC:68788-7745(NDC:49483-
602)
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
IBUPROFEN
400 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
white
SCORE
no score
SHAPE
ROUND
SIZE
13mm
FLAVOR
IMPRINT CODE
121
CONTAINS
Preferred Pharmaceuticals, Inc.
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:68788-
7745-2
20 in 1 BOTTLE; Type 0: Not a Combination
Product
07/01/2020
2
NDC:68788-
7745-8
28 in 1 BOTTLE; Type 0: Not a Combination
Product
07/01/2020
3
NDC:68788-
7745-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
07/01/2020
4
NDC:68788-
7745-5
50 in 1 BOTTLE; Type 0: Not a Combination
Product
07/01/2020
5
NDC:68788-
7745-6
60 in 1 BOTTLE; Type 0: Not a Combination
Product
07/01/2020
6
NDC:68788-
7745-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
07/01/2020
7
NDC:68788
                                
                                read_full_document
                                
                            

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