Prescription Drug Information: IBUPROFEN

IBUPROFEN- ibuprofen tablet, film coated
REMEDYREPACK INC.

ibuprofen tablets 400 mg — 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

HOW SUPPLIED

400mg (white to of white, round, biconvex, film coated tablets debossed with ’121′ on one side and plain on the other side) Bottles of 100 & 500

HOW SUPPLIED

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ’122′ on one side and plain on the other side) Bottles of 30, 50, 100 & 500

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)

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

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

ACTIVE INGREDIENT(S):

  • IBUPROFEN 800mg in 1

INACTIVE INGREDIENT(S):

  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • STARCH, PREGELATINIZED CORN
  • POLYVINYL ALCOHOL
  • TALC
  • SILICON DIOXIDE
  • CELLULOSE, MICROCRYSTALLINE
  • CROSCARMELLOSE SODIUM
  • MAGNESIUM STEARATE
  • TITANIUM DIOXIDE
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
MM3
(click image for full-size original)
MM4
(click image for full-size original)
MM5
(click image for full-size original)
MM6
(click image for full-size original)
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0005(NDC:49483-604)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0005-0 21 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:70518-0005-1 14 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:70518-0005-2 30 TABLET, FILM COATED in 1 BLISTER PACK None
4 NDC:70518-0005-3 10 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:70518-0005-4 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
6 NDC:70518-0005-5 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 11/17/2016
Labeler — REMEDYREPACK INC. (829572556)

Revised: 02/2020 REMEDYREPACK INC.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Medication Sections

Medication Information by RSS

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.