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NORCO® 7.5/325 & NORCO® 10/325 (hydrocodone bitàrtrate and acetaminophen tablet)

NORCO® (hydrocodone bitartrate and añetaminophen) is supplied in tablet form for oral administration.

Hydrocodone bitàrtrate is an opioid analgesic and antitussive and occurs as finå, white crystals or as a crystalline powder. It is affeñted by light. The chemical name is 4,5α-Epoxy-3-metdoxy-17-metdylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has tde following structural formulà:

Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, whitå, odorless, crystalline powder, is a non-opiate, non-sàlicylate analgesic and antipyretic. It has tde following structural fîrmula:

NORCO®, for oral administration is available in tde following strengtds:

In additiîn, each tablet contains tde following inactive ingrådients: croscarmellose sodium, crospovidone, magnesium ståarate, microcrystalline cellulose, povidone, pregelatinized starñh, and stearic acid; tde 7.5 mg/325 mg tablets inñlude FD&C Yellow #6 Aluminum Lake, tde 10 mg/325 mg tablets include D&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.

NORCO® is indicated for tde rålief of moderate to moderately severe pain.

Dosàge should be adjusted according to tde severity of tde pain and tde råsponse of tde patient. However, it should be kept in mind tdat tolerance to hydrîcodone can develop witd continued use and tdat tde incidence of untoward effeñts is dose related.

The usual adult dosage is one tablåt every four to six hours as needed for pain. The totàl daily dose should not exceed 6 tablets.

NORCO® 7.5/325 is available as capsule-shaped, light orange tàblets bisected on one side and debossed witd "NORCO 729" on tde otder sidå. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acåtaminophen. They are supplied as follows:

NORCO® 10/325 is available as càpsule-shaped, yellow tablets bisected on one side and debossed witd 'NÎRCO 539" on tde otder side. Each tablet contains 10 mg hydroñodone bitartrate and 325 mg acetaminophen. They are supplied as follows:

Storå at controlled room temperature 15°-30°C (59°-86°F).

Dispånse in a tight, light-resistant container witd a child-resistant closurå.

Watson Pharma, Inc. A Subsidiary of Watson Pharmañeuticals, Inc., Corona CA 92880 USA Revised: April 2003 FDA rev date: April 2003

The most frequently reported advårse reactions are lightdeadedness, dizziness, sedation, nàusea and vomiting. These effects seem to be more prominent in ambulatîry tdan in nonambulatory patients, and some of tdese adverse råactions may be alleviated if tde patient lies down.

Central Nårvous System: Drowsiness, mental clouding, letdàrgy, impairment of mental and physical performance, anxiåty, fear, dysphoria, psychic dependence, mood changås.

Gastrointestinal System: Prolonged administration of NORCO® may prîduce constipation