NDC Code(s) : 60687-141-11, 60687-141-21
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dextroamphetamine SulfateDextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-141(NDC:0555-0955)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHYLCELLULOSE (15 MPA.S)(UNII: NPU9M2E6L8)
POVIDONES(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color brown Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code barr;955
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-141-2130 in 1 BOX, UNIT-DOSE 07/01/2016
1NDC:60687-141-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076137 03/31/2015 04/30/2018

PRINCIPAL DISPLAY PANEL

Dextroamphetamine Sulfate Extended-Release Capsules CII 10 mg Label

NDC 60687-141-21

DEXTROAMPHETAMINE
SULFATE
Extended-Release
Capsules

CII

10 mg

30 Capsules (3 x 10)

PHARMACIST: Dispense with the accompanying
Medication Guide to each patient.

Each Capsule Contains:
Dextroamphetamine Sulfate, USP …………. 10 mg
so prepated that an intitial dose is released promtly and
the remaining medication is released gradually over a
prolonged period.

Usual Dosage: See package insert for full prescribing
information.

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

DEA Order Form Required.

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is
from NDC # 0555-0955, Teva Pharmaceuticals
USA.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

714121
Rev. 02/2015