Acetaminophen with codeine is not recommended during lactation because safety in nursing mothers has not been established. Acetaminophen passes into breast milk but is not likely to have an adverse effect on the infant at therapeutic doses. Some studies, but not others, have reported detectable amounts of codeine in breast milk. The levels are probably not clinically significant after usual therapeutic dosage. The possibility of clinically important amounts being excreted in breast milk in individuals abusing codeine should be considered.
Caffeine is found in breast milk following the consumption of tea or coffee.
Tablets and caplets should not be administered to children below the age of 12 years. Safe dosage of the elixir has not been established in infants below the age of 2 years. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of this product. These drugs should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.