Acetaminophen / diphenhydramine / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / diphenhydramine / phenylephrine is also known as: Benadryl Allergy Plus Cold, Benadryl Severe Allergy Plus Sinus Headache, CVS Allergy & Cold, CVS Allergy & Sinus Headache, Children's Tylenol Plus Cold And Allergy, CounterAct Night, Delsym Children’s Cough+ Cold Night Time, Delsym Cough+ Cold Night Time, Equate Allergy & Sinus Headache, Mucinex Children's Night Time Multi-Symptom Cold, Mucinex Fast-Max Night Time Cold & Flu, Mucinex Sinus-Max Day & Night (Night), Robitussin Multi-Symptom Cold Night Time, Robitussin Night Time Cough, Cold & Flu, Robitussin Peak Cold Nighttime Multi-Symptom Cold, Severe Allergy and Sinus Headache, Sudafed PE Nighttime Cold, Sudafed PE Severe Cold, Suphedrine PE Severe Cold, Theraflu Nighttime Severe Cold & Cough, Theraflu Warming Relief Flu & Sore Throat, Theraflu Warming Relief Nighttime Severe Cold & Cough, Theraflu Warming Relief Sinus & Cold, Tylenol Allergy Multi-Symptom Nighttime, Tylenol Plus Children's Cold & Allergy

Acetaminophen / diphenhydramine / phenylephrine Pregnancy Warnings

Acetaminophen has not been formally assigned to a pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Diphenhydramine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal teratogenicity. The Collaborative Perinatal Project reported 595 first-trimester exposures and 2,948 exposures anytime during pregnancy. No relationship was found to large categories of malformations. Possible associations with individual malformation were found. One study reported a statistical relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital. Phenylephrine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen/diphenhydramine/phenylephrine is only recommended for use during pregnancy when benefit outweighs risk.

Acetaminophen / diphenhydramine / phenylephrine Breastfeeding Warnings

Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. Small amounts of phenylephrine are secreted in breast milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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