ARTHROTEC (Page 11 of 11)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Label

Arthrotec® 50

50 mg diclofenac sodium/ 200 mcg misoprostol

Distributed by
G.D. Searle LLC
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet LabelPRINCIPAL DISPLAY PANEL — 50 mg Tablet Label

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0025-1411-60

Arthrotec® 50
diclofenac sodium and misoprostol
delayed-release tablets

50 mg/200 mcg

DOSAGE AND USE
See accompanying prescribing information.

60 Tablets Rx only

20688035

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label — 90

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0025-1411-90

Arthrotec® 50
diclofenac sodium and misoprostol
delayed-release tablets

50 mg/200 mcg

DOSAGE AND USE
See accompanying prescribing information.

90 Tablets Rx only

20688036

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Label -- 90
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0025-1411-34
100 Tablets
UNIT DOSE

2146
MADE IN ENGLAND

Arthrotec ® 50
50 mg diclofenac sodium/200 mcg misoprostol

50 mg/200 mcg

11004701

PRINCIPAL DISPLAY PANEL -- 50 mg Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg Tablet Label

Arthrotec® 75

75 mg diclofenac sodium/ 200 mcg misoprostol

Distributed by
G.D. Searle LLC
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 75 mg Tablet LabelPRINCIPAL DISPLAY PANEL — 75 mg Tablet Label

PRINCIPAL DISPLAY PANEL — 75 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0025-1421-60

Arthrotec® 75
diclofenac sodium and misoprostol
delayed-release tablets

75 mg/200 mcg

DOSAGE AND USE
See accompanying prescribing information.

60 Tablets Rx only

20688037

PRINCIPAL DISPLAY PANEL -- 75 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0025-1421-34
100 Tablets
UNIT DOSE

2149
MADE IN ENGLAND

Arthrotec ® 75
75 mg diclofenac sodium/200 mcg misoprostol

75 mg/200 mcg

11004901

PRINCIPAL DISPLAY PANEL -- 75 mg Carton
(click image for full-size original)
ARTHROTEC diclofenac sodium and misoprostol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1411
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 50 mg
MISOPROSTOL (MISOPROSTOL) MISOPROSTOL 200 ug
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROGENATED CASTOR OIL
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM HYDROXIDE
STARCH, CORN
TALC
TRIETHYL CITRATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code SEARLE;1411;AAAA;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0025-1411-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0025-1411-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0025-1411-34 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020607 12/24/1997
ARTHROTEC diclofenac sodium and misoprostol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1421
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 75 mg
MISOPROSTOL (MISOPROSTOL) MISOPROSTOL 200 ug
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROGENATED CASTOR OIL
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM HYDROXIDE
STARCH, CORN
TALC
TRIETHYL CITRATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code SEARLE;1421;AAAA;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0025-1421-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0025-1421-34 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020607 12/24/1997
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 943955690 ANALYSIS (0025-1411), ANALYSIS (0025-1421)

Revised: 05/2021 Pfizer Laboratories Div Pfizer Inc

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