APAP 325 MG hydrocodone bitartrate 5 MG Oral Tablet

INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.

American Health Packaging

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] nausea` `[3] fatigue` `[4] off label use` `[5] headache` `[6] diarrhoea` `[7] dyspnoea` `[8] pain` `[9] dizziness` `[10] vomiting`

9 years ago

OVAL WHITE IP 109

9 years ago

IP 109 OVAL WHITE

HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP, contain hydrocodone bitartrate 5 mg and acetaminophen 325 mg. They are supplied as white to off-white, scored, oblong biconvex tables, debossed "IP 109" on obverse and bisected on the reverse. They are available as follows: Unit dose packages of 100 (10x10) NDC 68084-368-01 Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°) [see USP Controlled Room Temperature]. A Schedule CIII Narcotic. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals, LLC as follows: (5 mg / 325 mg / 100 UD) NDC 68084-368-01 packaged from NDC 53746-109. Packaged and Distributed by: American Health Packaging Columbus, OH 43217 8236801/1011

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