Calcium Acetate: Package Insert and Label Information (Page 2 of 2)

16 HOW SUPPLIED/STORAGE AND HANDLING

Calcium Acetate capsules USP, 667 mg are hard gelatin capsules with blue opaque cap imprinted with “SUVEN” in white color ink and a white opaque body imprinted with “667” blue color ink. Each capsule contains 667 mg calcium acetate (anhydrous Ca(CH ₃ COO) ₂ ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.
NDC 16571-813-20 Bottles of 200 with child-resistant closure.

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Inform patients to take calcium acetate capsules with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [ see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].

Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after calcium acetate capsules.

Manufactured by:

Suven Pharmaceuticals Limited
Pashamylaram, Telangana, 502307, India
ML No: 24/MD/AP/2009/F/CC

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Revised: 09/2022

Lb50318-3-01

Calcium Acetate Capsules USP

Rising Pharmaceuticals NDC 16571-813-20

Calcium Acetate

Capsules USP

667 mg*

200 Capsules Rx Only

*Each capsule contains: 667 mg calcium

acetate, USP equivalent to 169 mg calcium

DIRECTIONS: SWALLOW CAPSULE. DO NOT

CHEW. Take as directed by your physician.

KEEP THIS AND ALL DRUGS OUT OF REACH

OF CHILDREN.

Store at 20° to 25°C (68° to 77°F); excursions

permitted to 15° to 30°C (59° to 86°F) [See USP

Controlled Room Temperature].

Manufactured By:

Suven Pharmaceuticals Limited
Pashamylaram, Telangana, 502307, India

M.L No.: 24/MD/AP/2009/F/CC

Distributed By:

Rising Pharma Holdings, Inc.
East Brunswick, NJ, 08816

Lb50318-1-00 Rev. 08/2021

CALCIUM ACETATE calcium acetate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-813 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM ACETATE (CALCIUM CATION) CALCIUM ACETATE 667 mg

Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 0.0061 mg WATER 13.9592 mg FD&C BLUE NO. 1 0.0555 mg FD&C BLUE NO. 1 ALUMINUM LAKE 0.0728 mg

Product Characteristics Color blue (Cap, Opaque) , white (Body,Opaque) Score score with uneven pieces Shape CAPSULE Size 22mm Flavor Imprint Code Suven;667 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16571-813-20 200 CAPSULE in 1 BOTTLE, PLASTIC None

(click image for full-size original)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211038 11/01/2021

Labeler — Rising Pharma Holdings, Inc. (835513529)

Establishment
Name	Address	ID/FEI	Operations
Suven Pharmaceuticals Limited		677604288	manufacture (16571-813), api manufacture (16571-813), analysis (16571-813), pack (16571-813), label (16571-813)

Revised: 10/2022 Rising Pharma Holdings, Inc.