Tramadol Hydrochloride and Acetaminophen Tablets

ULTRACET (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol hydrochloride and opioid agonist, and acetaminophen.

The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:

The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder.

The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is:

The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.

ULTRACET tablets contain 37.5 mg of tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are carnauba wax, corn starch, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized corn starch, sodium starch glycolate, and titanium dioxide.

Meets USP Dissolution Test 2.

Included as part of the PRECAUTIONS section.

Do not drink alcohol while you are taking acetaminophen and tramadol. Alcohol may cause a dangerous decrease in your breathing when used together with acetaminophen and tramadol. Alcohol may also increase your risk of liver damage while taking acetaminophen.

Acetaminophen and tramadol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.