IBUPROFEN tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
07-07-2022

Aktiv ingrediens:

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

Tilgjengelig fra:

Preferred Pharmaceuticals Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Produkt oppsummering:

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on 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: 7/2022
Document Id: eaa39be7-ba41-4c20-8330-a44d52602860
34391-3
Set id: f4b778cf-0741-46b3-ace9-7ac8d0695e31
Version: 3
Effective Time: 20220707
Preferred Pharmaceuticals Inc.
                                
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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
800 mg (white to off-white, capsule shaped, biconvex, film-coated​
tablets debossed with
‘123’ on one side and plain on other side)
Repackaged By: Preferred Pharmaceuticals Inc.
800MG LABEL
IBUPROFEN
ibuprofen tablet, film coated
Bottles of 14 NDC 68788-7079-4
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION
DRUG
ITEM CODE
(SOURCE)
NDC:68788-7079(NDC:49483-
604)
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
IBUPROFEN
800 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
CAPSULE
SIZE
19mm
FLAVOR
IMPRINT CODE
123
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:68788-
7079-4
14 in 1 BOTTLE; Type 0: Not a Combination
Product
06/17/2020
2
NDC:68788-
7079-2
20 in 1 BOTTLE; Type 0: Not a Combination
Product
06/17/2020
3
NDC:68788-
7079-7
21 in 1 BOTTLE; Type 0: Not a Combination
Product
06/17/2020
4
NDC:68788-
7079-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
06/17/2020
5
NDC:68788-
7079-5
50 in 1 BOTTLE; Type 0: Not a Combination
Product
06/17/2020
6
NDC:68788-
7079-6
60 in 1 BOTTLE; Type 0: Not a Combination
Product
06/17/2020
7
NDC:68788-
7079-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
06/17/2020
8
NDC:68788-
7079-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
06/17/2020
9
NDC:68788-
120 in 1 BOTTLE; Type 0: Not a Combination
06/17/2
                                
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