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)
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
PACKAGE LABEL PRINCIPAL DISPLAY PANEL (1000 Caps)
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
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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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