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If this SPL includes inactivated NDCs outlined with the FDA initiated compliance motion, They are going to be specified as a result.

Even though taking acetaminophen and codeine phosphate tablets Never: Push or operate major equipment, till you know how acetaminophen and codeine phosphate tablets impact you. Acetaminophen and codeine phosphate tablets will make you sleepy, dizzy, or lightheaded.

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Acetaminophen and codeine phosphate tablets need to be prescribed only by Health care specialists who are educated about the usage of opioids and how to mitigate the involved pitfalls.

Propulsive peristaltic waves within the colon are lessened, although tone could be increased to The purpose of spasm, leading to constipation. Other opioid-induced consequences could include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Assess Every affected person’s possibility for opioid dependancy, abuse, or misuse previous to prescribing acetaminophen and codeine phosphate tablets, and reassess all people receiving acetaminophen and codeine phosphate tablets for the event of such behaviors and disorders. Risks are elevated in sufferers with a personal or household historical past of material abuse (which include drug or Alcoholic beverages abuse or addiction) or mental sickness (e.g., main melancholy). The likely for these challenges must not, on the other hand, reduce the proper management of pain in any given patient.

Inform individuals that opioids could cause a unusual but likely life-threatening situation resulting from concomitant administration of serotonergic drugs. Warn people of the signs and symptoms and signs of serotonin syndrome and to seek medical attention straight away if indicators produce.

Titrate the dose dependent upon the individual patient’s reaction to their First dose of acetaminophen and codeine phosphate tablets.

Right before using this medication, Girls of childbearing age should talk to their doctor(s) regarding the threats and Rewards. Convey to your medical doctor more info When you are pregnant or if you propose to be pregnant. During pregnancy, this medication must be used only when Obviously needed. It could a little bit raise the possibility of beginning defects if applied throughout the to start with two months of here pregnancy. Also, making use of it for a very long time here or in higher doses near the predicted delivery date may well click here hurt the unborn newborn.

You can find inter-affected person variability during the website potency of opioid prescription drugs and opioid formulations. As a result, a conservative technique is suggested when deciding the total everyday dosage of acetaminophen and codeine phosphate tablets.

After halting usage of a CYP2D6 inhibitor, contemplate cutting down the acetaminophen and codeine phosphate tablets dosage and evaluate the individual at Repeated intervals for signs and signs of respiratory melancholy or sedation (see Safety measures, Drug Interactions).

Acetaminophen and codeine phosphate tablets, like other opioids, may be diverted for nonmedical use into illicit channels of distribution.

Will not give acetaminophen and codeine phosphate tablets to a baby younger than eighteen many years of age just after surgical treatment to eliminate the tonsils and/or adenoids.

Advise individuals that acetaminophen and codeine phosphate tablets may perhaps impair the mental and/or physical talents needed for that performance of doubtless harmful duties for instance driving a car or running equipment and to prevent these tasks while getting this products, until finally they know the way they'll respond into the medication.