Advil PM

Advil PM is part of the drug class:

• Aminoalkyl ethers

Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Antihistamines can cause drowsiness, which can aid in the treatment of occasional sleep problems (insomnia).

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Diphenhydramine and ibuprofen is a combination medicine used to treat occasional insomnia associated with minor aches and pains.

Diphenhydramine and ibuprofen is not for use in treating sleeplessness without pain, or sleep problems that occur often.

Diphenhydramine and ibuprofen may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Use Advil PM as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Take this medicine at bedtime.

What do I do if I miss a dose?

• If you take Advil PM on a regular basis, take a missed dose as soon as you think about it.
• If you will not be able to get a full night's sleep (at least 7 hours) after taking the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Advil PM, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Advil PM. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Advil PM.

Review Date: October 4, 2017

Applies to diphenhydramine / ibuprofen: oral capsule, oral tablet

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Feeling sleepy.
• Belly pain or heartburn.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

DiphenhydrAMINE-ibuprofen 38 mg-200 mg oral tablet:
2 tablets orally at bedtime not to exceed 2 tablets daily.

DiphenhydrAMINE-ibuprofen 25 mg-200 mg oral capsule:
2 capsules orally at bedtime not to exceed 2 capsules daily.

Data not available

Diphenhydramine-ibuprofen has not been formally assigned to a pregnancy category by the FDA. 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. Ibuprofen has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. While there are no literature reports linking the use of ibuprofen in pregnancy with birth defects, use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Diphenhydramine-ibuprofen should only be given during pregnancy when benefit outweighs risk. Ibuprofen should be avoided near term (last three months of pregnancy).

One manufacturer of ibuprofen has reported on 50 in utero exposures to ibuprofen. Seven cases were reported retrospectively and included one-third trimester fetal death of unknown cause, one spontaneous abortion without evidence of abnormalities, anencephaly (N=1), petit mal seizures progressing to grand mal seizures (N=1), cerebral palsy (N=1), microphthalmia, nasal cleft, and mildly rotated palate (N=1), and tooth staining (N=1). Of the 43 prospective cases, 23 were followed to a normal delivery. Of the remaining cases, one ended in a stillbirth without abnormalities, one ended in a spontaneous abortion without abnormalities, and the remaining were lost to follow-up.