SEMPREX-D (acrivastine and pseudoephedrine) Capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. SEMPREX-D (acrivastine and pseudoephedrine) 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 (acrivastine and pseudoephedrine) Capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials.

SEMPREX-D (acrivastine and pseudoephedrine) Capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold.

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.

SEMPREX-D (acrivastine and pseudoephedrine) 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 (acrivastine and pseudoephedrine) ” 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. Rev. 07/2007.

Last reviewed on RxList: 5/20/2009
This monograph has been modified to include the generic and brand name in many instances.