Acamprosate Calcium: Package Insert and Label Information (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE NDC 42291-104-18
Acamprosate Calsium Delayed-release Tablets
333 mg
180 Tablets Rx Only

Each enteric-coated, delayed-release tablet contains 333 mg of acamprosate calcium.
Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. A 09/15 AV 05/16 (P)

N 3 42291 10418 1

label
(click image for full-size original)
ACAMPROSATE CALCIUM
acamprosate calcium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-104(NDC:0093-5352)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACAMPROSATE CALCIUM (ACAMPROSATE) ACAMPROSATE CALCIUM 333 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (12 MPA.S AT 5%)
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MAGNESIUM TRISILICATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
PROPYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 77;1140
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-104-18 180 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200143 05/16/2016
Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE

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