Darvon (Propoxyphene Hydrochloride) - Indications and Dosage

INDICATION

This product is indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever.

DOSAGE AND ADMINISTRATION

These products are given orally. For propoxyphene hydrochloride, the usual dose is 65 mg propoxyphene hydrochloride (with or without 389 mg aspirin, and 32.4 mg caffeine) every 4 hours as needed for pain. The maximum recommended dose of propoxyphene hydrochloride is 390 mg per day.

For propoxyphene napsylate, the usual dosage is 100 mg propoxyphene napsylate (with or without 650 mg acetaminophen) every 4 hours as needed for pain. The maximum recommended dose of propoxyphene napsylate is 600 mg per day.

Consideration should be given to a reduced total daily dosage in patients with hepatic or renal impairment.

HOW SUPPLIED

Darvocet A500™ Tablets are available in:

The 100 mg/500 mg are available as dark orange, film coated, oval shaped tablets debossed "A500" on both sides.

Bottles of 100 Tablets NDC 66591-691-41

Darvocet-N® 50 Tablets are available in:

The 50 mg tablets are dark orange, capsule shaped, film coated, and imprinted with the script "Darvocet-N 50" on one side of the tablet, using edible black ink.

They are available as follows:

Bottles of 100 (RxPak *) NDC 66591-651-41

Darvocet-N® 100 Tablets are available in:

The 100 mg tablets are dark orange, capsule shaped, film coated, and imprinted with the script "Darvocet-N 100" on one side of the tablet, using edible black ink.

They are available as follows:

Bottles of 100 (RxPak *) NDC 66591-641-41

Bottles of 500 NDC 66591-641-51

Darvon-N® Tablets are available in:

The 100 mg tablets are buff colored, elliptical shaped, film coated, and imprinted with the script "Darvon-N 100" on one side of the tablet, using edible black ink.

They are available as follows:

Bottles of 100 (RxPak *) NDC 66591-631-41

Bottles of 500 NDC 66591-631-51

Darvon® Pulvules® are available in:

The 65 mg parabolic-shaped capsules are imprinted with the script "Lilly" and "H03" on the opaque pink cap and "Darvon" on the opaque pink body, using edible black ink.

They are available as follows:

Bottles of 100 (RxPak *) NDC 0002-0803-02 (PU0365)

Bottles of 500 NDC 0002-0803-03 (PU0365)

ID ^**/* 100 NDC 0002-0803-33 (PU0365)

Darvon® Compound-65 Pulvules® are available in:

The 65 mg parabolic-shaped capsules are imprinted with the script "Lilly" and "3111" on the opaque gray cap and "Darvon Comp 65" on the opaque red body, using edible black ink.

They are available as follows:

Bottles of 100 (RxPak *) NDC 0002-3111-02 (PU0369)

Bottles of 500 NDC 0002-3111-03 (PU0369)

Store at 25°C (77°F); excursions are permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature]

CAUTION --Rx only

Literature revised June 2004.

Darvocet A500 manufactured by: Mikart, Inc.

Darvon, Darvon Compound 65, Darvon N,

Darvocet-N50 & Darvocet-N100

manufactured by: Eli Lilly & Company, Inc.

Manufactured For:

aai Pharma®

Pulvules and Identi-Dose are registered trademarks of Eli Lilly and Company, Inc

Darvon, Darvon-N and Darvocet-N are registered trademarks of aaiPharma LLC

Darvocet A500 is a trademark of aaiPharma Inc