Semprex-D (Page 4 of 4)

DOSAGE AND ADMINISTRATION

The recommended dosage for adults and adolescents 12 years and older is one capsule administered orally, every 4 to 6 hours four times a day.

HOW SUPPLIED

SEMPREX-D Capsules (dark green opaque cap and white opaque body with a yellow band) contain acrivastine 8 mg and pseudoephedrine hydrochloride 60 mg. The cap is printed with “404” in white ink, and the body is printed with “SEMPREX-D” in black ink.

NDC 53014-404-10 Bottle of 100’s

Storage

Store at 15° to 25° C (59° to 77° F) in a dry place and protected from light.

Keep out of the reach of children.

For Medical Information

Contact: Medical Affairs Department
Phone: (866) 822-0068
Fax: (770) 970-8859

Marketed by:

UCB, Inc.
Smyrna, GA 30080

Manufactured by:
DSM Pharmaceuticals, Inc.
Greenville, NC 27834 USA

SEMPREX is a registered trademark of UCB, Inc., Smyrna, GA 30080
© 2007, UCB, Inc., Smyrna, GA 30080
All rights reserved.

Rev. 1E 07/2007 003419

SEMPREX-D acrivastine and pseudoephedrine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53014-404
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
acrivastine (acrivastine) acrivastine 8 mg
pseudoephedrine hydrochloride (pseudoephedrine) pseudoephedrine 60 mg
Inactive Ingredients
Ingredient Name Strength
lactose
magnesium stearate
sodium starch glycolate
gelatin
D&C Yellow No. 10
FD&C Green No. 3
titanium dioxide
Product Characteristics
Color green (dark green opaque) , white (white opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 404;SEMPREX-D
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53014-404-10 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
Labeler — UCB, Inc.

Revised: 05/2008 UCB, Inc.

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