IBUPROFEN tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Navodilo za uporabo (PIL)
29-02-2024
Prenos Lastnosti izdelka (SPC)
29-02-2024

Aktivna sestavina:

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

Dostopno od:

REMEDYREPACK INC.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Povzetek izdelek:

Ibuprofen 400mg, white, round, tablet, imprint: 121 NDC: 70518-2432-00 NDC: 70518-2432-01 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

                                REMEDYREPACK INC.
----------
IBUPROFEN TABLETS 400 MG - 600 MG-
800 MG MEDGUIDE
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762
Revised: 2/2024
Document Id: 1286c192-bcea-647a-e063-6294a90a5a2e
34391-3
Set id: a7756b22-73cf-4262-aa8e-0577ddecd03b
Version: 5
Effective Time: 20240229
REMEDYREPACK INC.
                                
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Lastnosti izdelka

                                IBUPROFEN- IBUPROFEN TABLET, FILM COATED
REMEDYREPACK INC.
----------
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS
IBUPROFEN TABLETS 400 MG - 600 MG- 800 MG MEDGUIDE
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762
Ibuprofen 400mg, white, round, tablet, imprint: 121
NDC: 70518-2432-00
NDC: 70518-2432-01
PACKAGING: 21 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
PRINCIPAL DISPLAY PANEL
DRUG: IBUPROFEN
GENERIC: IBUPROFEN
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-2432-0
NDC: 70518-2432-1
COLOR: white
SHAPE: ROUND
SCORE: No score
SIZE: 13 mm
IMPRINT: 121
PACKAGING: 21 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
IBUPROFEN 400mg in 1
INACTIVE INGREDIENT(S):
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
IBUPROFEN
ibuprofen tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION
DRUG
ITEM CODE
(SOURCE)
NDC:70518-2432(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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED 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
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70518-
2432-0
21 in 1 BLISTER PACK; Type 0: Not a Combination
Product
11/1
                                
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