FOSAMAX PLUS D (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 70 mg/2800 IU Tablet Blister Pack

FOSAMAX® PLUS D
(alendronate sodium/
cholecalciferol) tablets

70 mg
2800 IU

Dispense the enclosed
Medication Guide to
each patient.

Each tablet contains
91.37 mg alendronate
sodium (70 mg free acid
equivalent) and 70 mcg
cholecalciferol
equivalent to 2800 IU
vitamin D.

710

4 Tablets

Rx only

USUAL ADULT DOSAGE:
ONE 70 mg/2800 IU TABLET
ONCE WEEKLY

See accompanying circular
for dosage information.

Manuf. for: Organon LLC,
a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

By:
Rovi Pharma Industrial Services, S.A.
28805 Alcalá de HenaresMadrid, Spain

Made in Spain

PRINCIPAL DISPLAY PANEL -- 70 mg/2800 IU Tablet Blister Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 70 mg/5600 IU Tablet Blister Pack

FOSAMAX® PLUS D
(alendronate sodium/
cholecalciferol) tablets

70 mg
5600 IU

Dispense the enclosed
Medication Guide to
each patient.

Each tablet contains
91.37 mg alendronate
sodium (70 mg free acid
equivalent) and 140 mcg
cholecalciferol
equivalent to 5600 IU
vitamin D.

270

4 Tablets

Rx only

USUAL ADULT DOSAGE:
ONE 70 mg/5600 IU
TABLET ONCE WEEKLY

See accompanying circular
for dosage information.

Manuf. for: Organon LLC,
a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

By:
Rovi Pharma Industrial Services, S.A.
28805 Alcalá de HenaresMadrid, Spain

Made in Spain

PRINCIPAL DISPLAY PANEL -- 70 mg/5600 IU Tablet Blister Pack
(click image for full-size original)
FOSAMAX PLUS D alendronate sodium and cholecalciferol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-137
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 70 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 2800 [iU]
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GELATIN, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SUCROSE
STARCH, CORN
MEDIUM-CHAIN TRIGLYCERIDES
SODIUM ALUMINOSILICATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (capsule-shaped) Size 12mm
Flavor Imprint Code 710
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78206-137-01 4 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021762 06/01/2021
FOSAMAX PLUS D alendronate sodium and cholecalciferol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 70 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 5600 [iU]
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GELATIN, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SUCROSE
STARCH, CORN
MEDIUM-CHAIN TRIGLYCERIDES
SODIUM ALUMINOSILICATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape RECTANGLE (rectangle-shaped) Size 11mm
Flavor Imprint Code 270
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78206-136-01 4 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021762 06/01/2021
Labeler — Organon LLC (117494753)

Revised: 06/2022 Organon LLC

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