Semprex-D (Acrivastine / Pseudoephedrine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

SEMPREX-D Capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. SEMPREX-D Capsules should be administered when both the antihistaminic activity of acrivastine and the nasal decongestant activity of pseudoephedrine are desired (see CLINICAL PHARMACOLOGY). The efficacy of SEMPREX-D Capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials.

SEMPREX-D Capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold.

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

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.

Marketed by:

Celltech Pharmaceuticals, Inc.
Rochester, NY 14623 USA

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

U.S. Patent No. 4650807.
® Celltech Manufacturing CA, Inc.
© 2004, Celltech Pharmaceuticals, Inc. All rights reserved.

Rev. 4/04
R532B
000281