Label: IBUPROFEN tablet, film coated
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NDC Code(s):
70518-0005-0,
70518-0005-1,
70518-0005-2,
70518-0005-3, view more70518-0005-4, 70518-0005-5, 70518-0005-6
- Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 49483-604
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 3, 2024
If you are a consumer or patient please visit this version.
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- Medication Guide: HTML
- Official Label (Printer Friendly)
- 1. ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
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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)
NDC: 70518-0005-00
NDC: 70518-0005-01
NDC: 70518-0005-02
NDC: 70518-0005-03
NDC: 70518-0005-04
NDC: 70518-0005-05
NDC: 70518-0005-06
PACKAGING: 21 in 1 BLISTER PACK
PACKAGING: 14 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 10 in 1 BLISTER PACK
PACKAGING: 90 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BLISTER PACK
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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PRINCIPAL DISPLAY PANEL
DRUG: IBUPROFEN
GENERIC: IBUPROFEN
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-0005-0
NDC: 70518-0005-1
NDC: 70518-0005-2
NDC: 70518-0005-3
NDC: 70518-0005-4
NDC: 70518-0005-5
NDC: 70518-0005-6
COLOR: white
SHAPE: CAPSULE
SCORE: No score
SIZE: 19 mm
IMPRINT: 123
PACKAGING: 21 in 1 BLISTER PACK
PACKAGING: 14 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 10 in 1 BLISTER PACK
PACKAGING: 90 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- IBUPROFEN 800mg in 1
INACTIVE INGREDIENT(S):
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL
- STARCH, PREGELATINIZED CORN
- TALC
- TITANIUM DIOXIDE
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0005(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 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70518-0005-0 21 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/17/2016 06/04/2018 2 NDC:70518-0005-1 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/05/2016 06/01/2018 3 NDC:70518-0005-2 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/13/2016 06/11/2018 4 NDC:70518-0005-3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/27/2017 06/11/2018 5 NDC:70518-0005-4 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/06/2017 03/30/2021 6 NDC:70518-0005-5 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2017 06/28/2018 7 NDC:70518-0005-6 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090796 11/17/2016 Labeler - REMEDYREPACK INC. (829572556)