TEMAZEPAM (Page 5 of 5)

Package/Label Display Panel – Carton – 7.5 mg

7.5 mg Temazepam Capsules Carton
(click image for full-size original)

NDC 68084- 549 -21

Temazepam
Capsules USP CIV

7.5 mg

30 Capsules (3 x 10)                Rx Only

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

Each Capsule Contains:
Temazepam USP ………………………………………………………..7.5 mg

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].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0406-9960, SpecGx LLC.

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

054921 0254921/0918

Package/Label Display Panel – Blister – 7.5 mg

7.5 mg Temazepam Capsule Blister
(click image for full-size original)

Temazepam Capsule USP       CIV

7.5 mg

TEMAZEPAM temazepam capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-549(NDC:0406-9960)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMAZEPAM (TEMAZEPAM) TEMAZEPAM 7.5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FERRIC OXIDE RED
TITANIUM DIOXIDE
BUTYL ALCOHOL
SHELLAC
ALCOHOL
ETHYL ACETATE
Product Characteristics
Color pink, blue Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code FOR;SLEEP;M;7;5;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-549-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-549-11)
1 NDC:68084-549-11 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-549-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018163 12/14/2011
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-549)

Revised: 11/2019 American Health Packaging

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