FOSAMAX (Page 8 of 8)

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

For patent information: www.organon.com/our-solutions/patent/

Copyright © 2021 Organon Global Inc.
All rights reserved.

Revised: 6/2021

usmg-og0217-mf-2106r000

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PRINCIPAL DISPLAY PANEL — 4 Tablet Blister Pack

ONCE WEEKLY
FOSAMAX^® 70 mg
(Alendronate SodiumTablets)

Dispense the enclosed
Medication Guide
to each patient.

Each tablet contains
91.37 mg
alendronate sodium
(70 mg free acid
equivalent)

4 Tablets

Rx only

USUAL ADULT
DOSAGE:
ONE 70 mg TABLET
ONCE WEEKLY

See accompanying
circular for complete
dosage information.

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

Manuf. by:
Aesica Pharmaceuticals GmbH
Galileistraβe 6, 08056 Zwickau, Germany

Alendronate Sodium(active ingred.) Made in Ireland.

Formulated in Germany.

Copyright © 2021 Organon Global Inc. All rights reserved.

FOSAMAX alendronate sodium tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-135 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 70 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE

Product Characteristics Color WHITE (white) Score no score Shape OVAL (oval) Size 13mm Flavor Imprint Code 31 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78206-135-01 4 TABLET in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020560 06/01/2021

Labeler — Organon LLC (117494753)

Revised: 06/2022 Organon LLC