CALCIUM ACETATE (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Calcium Acetate Capsules are blue opaque capsules imprinted with “EP 115” for oral administration containing 667 mg calcium acetate (anhydrous Ca(CH3 COO)2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.

Capsule

NDC 68382-539-66 Bottles of 200

NDC 68382-539-10 Bottles of 1000

STORAGE: Store at 25°C (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 and efficacy to take the drug one hour before or three hours after calcium acetate capsules.

Manufactured for

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Manufactured by

Emcure Pharmaceuticals USA Inc.

21-B Cotters Lane

East Brunswick, NJ 08816

PACKAGE LABEL PRINCIPAL DISPLAY PANEL (200 Caps)

CALCIUM ACETATE Capsules

667 mg*

Rx only

NDC 68382-539-66

200 Capsules

*Each capsule contains:

667 mg calcium acetate equivalent to 169 mg calcium

DIRECTIONS : SWALLOW CAPSULES. DO NOT CHEW.

Take as directed by your physician.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Store at 25o C (77o F); excursions permitted to 15 to 30o C (59 to 86o F)

[See USP Controlled Room Temperature]

Manufactured by:

Emcure Pharmaceuticals USA Inc.

21-B Cotters Lane

East Brunswick, NJ 08816

Distributed by:

Zydus Pharmaceuticals USA Inc.

73 Route 31 North

Pennington, NJ 08534

label-200 casules
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL (1000 Caps)

CALCIUM ACETATE Capsules

667 mg*

Rx only

NDC 68382-539-10

1000 Capsules

*Each capsule contains:

667 mg calcium acetate equivalent to 169 mg calcium

DIRECTIONS : SWALLOW CAPSULES. DO NOT CHEW.

Take as directed by your physician.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Store at 25o C (77o F); excursions permitted to 15 to 30o C (59 to 86o F)

[See USP Controlled Room Temperature]

Manufactured by:

Emcure Pharmaceuticals USA Inc.

21-B Cotters Lane

East Brunswick, NJ 08816

Distributed by:

Zydus Pharmaceuticals USA Inc.

73 Route 31 North

Pennington, NJ 08534

label-1000 capsules
(click image for full-size original)
CALCIUM ACETATE calcium acetate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-539
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
MAGNESIUM STEARATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
TITANIUM DIOXIDE
GELATIN
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
FERRIC ACETATE, BASIC
Product Characteristics
Color BLUE (Opaque) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code EP115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-539-66 200 CAPSULE in 1 BOTTLE None
2 NDC:68382-539-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202315 07/07/2015
Labeler — Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Heritage Pharma Labs, Inc 189630168 analysis (68382-539), label (68382-539), manufacture (68382-539), pack (68382-539)

Revised: 07/2015 Zydus Pharmaceuticals USA Inc.

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