If this SPL includes inactivated NDCs mentioned from the FDA initiated compliance motion, They are going to be specified therefore.
There is not any information on the effects of codeine on milk creation. As a result of possible for critical adverse reactions, including surplus sedation, respiratory despair, and death inside a breastfed toddler, recommend individuals that breastfeeding is not really recommended all through procedure with acetaminophen and codeine phosphate tablets (see WARNINGS).
Quite a few acute ache ailments (e.g., the suffering that occurs with quite a few surgical procedures or acute musculoskeletal injuries) demand no quite a lot of days of an opioid analgesic. Clinical suggestions on opioid prescribing for many acute suffering conditions are available.
No nonclinical fertility research have already been done with codeine or The mixture of codeine and acetaminophen.
In the same way there was no proof of carcinogenicity exercise in male and female mice at dietary doses approximately 400 mg/kg/day of codeine sulfate (roughly five periods the maximum proposed daily dose of 360 mg/day for Grown ups over a mg/m2 foundation) for two years.
Embryo-Fetal Toxicity Notify feminine patients of reproductive likely that acetaminophen and codeine phosphate tablets can result in fetal damage and to tell the prescriber of a recognized or suspected pregnancy (see PRECAUTIONS, Pregnancy).
Notify clients that usage of opioids for an prolonged stretch of time may well cause minimized fertility. It isn't recognized irrespective of whether these outcomes on fertility are reversible (see ADVERSE REACTIONS).
Appropriate assessment on the individual, good prescribing methods, periodic reevaluation of therapy, and good dispensing and storage are appropriate measures that enable to Restrict abuse of opioid drugs.
To scale back the risk of respiratory despair, correct dosing and titration of acetaminophen and codeine phosphate tablets are important (see DOSAGE AND ADMINISTRATION).
The precise system with the analgesic Qualities of acetaminophen is not set up but is thought to involve central steps.
Screen patients check here for chance of material use disorders, including opioid abuse and misuse, and alert them of the chance for overdose and Loss of life linked to using further CNS depressants which includes Liquor and illicit medicine (see Safeguards, Drug Interactions and Information for Patients/Caregivers).
Fetal/Neonatal Adverse Reactions Utilization of opioid analgesics for an extended length of time for the duration of pregnancy for health-related or nonmedical purposes may result in Bodily dependence from the neonate and neonatal opioid withdrawal syndrome Soon after start.
Utilization of opioids check here for an prolonged length of time may well result in lessened fertility in females and males of reproductive prospective. It is far from recognised no matter get more info whether these outcomes on fertility are reversible (see ADVERSE REACTIONS).
This mixture medication is used to support decrease gentle to average pain. It is made up of an opioid get more info discomfort reliever (codeine) along with a non-opioid ache reliever rophynol clinic near me (acetaminophen). Codeine operates while in the Mind to change how Your entire body feels and responds to discomfort. Acetaminophen may reduce a fever. Look at Additional