Paracetamol/Caffeine

DEA Class;  OTC

Common Brand Names; Excedrin Tension Headache, Excedrin Aspirin Free, APAP-Plus

Analgesics, Other combo

Hypersensitivity

Hepatitis or severe hepatic/renal impairment

Discontinue use and ask a healthcare professional if any new symptoms occur, painful area is red or swollen, pain gets worse or lasts for more than 10 days, fever gets worse or lasts for more than 3 days

Pregnancy

Acetaminophen

Drug crosses placenta and can be detected in cord blood, newborn serum, and urine immediately after delivery

Increased risk of teratogenic effects not reported following maternal use of drug during pregnancy

Use of normal doses during pregnancy not associated with increased risk of miscarriage or stillbirth; however, increase in fetal death or spontaneous abortion may be seen with maternal overdose if treatment delayed

Wheezing and asthma in early childhood associated with frequent maternal use of drug during pregnancy

Caffeine

Caffeine crosses placenta; serum concentration in fetus are similar to that of the mother; dietary exposure unlikely to cause congenital malformations; unknown whether it may increase risk of other adverse events, including abortion or growth retardation

Current maternal consumption of high amounts of caffeine during pregnancy may lead to neonatal withdrawal at delivery; current guidelines recommend limiting caffeine intake from all sources to <200 mg/day during pregnancy

Lactation

Acetaminophen

Drug is excreted in milk; in general, breastfeeding is generally acceptable if relative infant dose (RID) is <10%; avoid breastfeeding when RID>25%

Caffeine

Caffeine and metabolites are present in breast milk; moderate amounts of caffeine are considered acceptable with breastfeeding; ingestion of <300 mg/day recommended; use caution if breastfeeding premature infants, or infants small for gestational age, or consuming unusually high amounts of caffeine

acetaminophen/caffeine

gel tab

• 500mg/65mg

tablet

• 500mg/65mg

caplet

• 500mg/65mg