IBUPROFEN tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Northwind Pharmaceuticals

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. CONTRAINDICATIONS Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have

Prehľad produktov:

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side) NDC: 51655-275-54 15 Bottles NDC: 51655-275-20 20 Bottles NDC: 51655-275-21 21 Bottles NDC: 51655-275-25 60 Bottles NDC: 51655-275-26 90 Botlles

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Northwind Pharmaceuticals
----------
IBUPROFEN TABLETS 400 MG - 600 MG-
800 MG MEDGUIDE
Revised: 1/2023
Document Id: d9f2ae7d-6c41-6429-e053-2a95a90ab8dc
34391-3
Set id: c20f1f4d-59b3-6bbe-e053-2a95a90abaf1
Version: 2
Effective Time: 20230101
Northwind Pharmaceuticals

Súhrn charakteristických

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
NORTHWIND PHARMACEUTICALS
----------
IBUPROFEN 800 MG TABLETS
IBUPROFEN TABLETS 400 MG - 600 MG- 800 MG MEDGUIDE
800 mg (white to off-white, capsule shaped, biconvex, film-coated​
tablets debossed with
‘123’ on one side and plain on other side)
NDC: 51655-275-54 15 Bottles
NDC: 51655-275-20 20 Bottles
NDC: 51655-275-21 21 Bottles
NDC: 51655-275-25 60 Bottles
NDC: 51655-275-26 90 Botlles
800 MG 20 COUNT LABEL
NDC: 51655-275-20
IBUPROFEN
ibuprofen tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION
DRUG
ITEM CODE
(SOURCE)
NDC:51655-275(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)
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
CAPSULE
SIZE
19mm
FLAVOR
IMPRINT CODE
123
Northwind Pharmaceuticals
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:51655-
275-20
20 in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
07/09/2021
2
NDC:51655-
275-21
21 in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
10/29/2020
3
NDC:51655-
275-25
60 in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
02/17/2021
4
NDC:51655-
275-26
90 in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
06/16/2020
5
NDC:51655-
275-54
15 in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
09/21/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA090796
06/16/2020
LABELER -
Northwind Pharmac