Acetaminophen / diphenhydramine / phenylephrine Pregnancy and Breastfeeding Warnings
Acetaminophen / diphenhydramine / phenylephrine is also known as: Benadryl Allergy Plus Cold, Benadryl Allergy Plus Sinus Headache, Benadryl Severe Allergy Plus Sinus Headache, CVS Allergy & Cold, CVS Allergy & Sinus Headache, Children's Tylenol Plus Cold And Allergy, CounterAct Night, Equate Allergy & Sinus Headache, 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.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.