Prescription Drug Information: Ibuprofen (Page 4 of 4)

Package/Label Display Panel – Blister – 400 mg

400 mg Ibuprofen Tablet Blister
(click image for full-size original)

Ibuprofen Tablet, USP

400 mg

Package/Label Display Panel – Carton – 600 mg

600 mg Ibuprofen Tablets Carton
(click image for full-size original)

NDC 60687- 457 -01

Ibuprofen
Tablets, USP

600 mg

100 Tablets (10 x 10) Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Ibuprofen, USP……………………………………………………600 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Avoid excessive heat 40°C (104°F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 65162-465, Amneal Pharmaceuticals LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

745701 0445701/0319

Package/Label Display Panel – Blister – 600 mg

600 mg Ibuprofen Tablet Blister
(click image for full-size original)

Ibuprofen Tablet, USP

600 mg

Package/Label Display Panel – Carton – 800 mg

800 mg Ibuprofen Tablets Carton
(click image for full-size original)

NDC 60687- 468 -01

Ibuprofen
Tablets, USP

800 mg

100 Tablets (10 x 10) Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Ibuprofen, USP……………………………………………………800 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Avoid excessive heat 40°C (104°F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 65162-466, Amneal Pharmaceuticals LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

746801 0446801/0319

Package/Label Display Panel – Blister – 800 mg

800 mg Ibuprofen Tablet Blister
(click image for full-size original)

Ibuprofen Tablet, USP

800 mg

IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-446(NDC:65162-464)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
TALC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex) Size 13mm
Flavor Imprint Code IP;464
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-446-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-446-11)
1 NDC:60687-446-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-446-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 06/01/2019
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-457(NDC:65162-465)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
TALC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL (Biconvex) Size 17mm
Flavor Imprint Code IP;465
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-457-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-457-11)
1 NDC:60687-457-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-457-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 06/01/2019
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-468(NDC:65162-466)
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
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
TALC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE (Biconvex) Size 19mm
Flavor Imprint Code IP;466
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-468-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-468-11)
1 NDC:60687-468-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-468-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 06/01/2019
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-446), repack (60687-457), repack (60687-468)

Revised: 11/2020 American Health Packaging

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