Diphenhydramine/Ibuprofen

DEA Class; OTC

Common Brand Names; Advil PM

NSAIDs; 

Sedative/Hypnotics

Oral non-prescription combination product containing a sedating antihistamine and a non-steroidal anti-inflammatory agent (NSAID)
Used for the occasional relief of insomnia associated with minor aches and pains in patients 12 years of age and older
Use for the shortest possible duration, as the risk for gastrointestinal or other adverse effects may increase with prolonged use

For the occasional treatment of insomnia associated with minor aches and mild pain.

Hypersensitivity to NSAIDs or aspirin

Active GI bleeding disorder

Breastfeeding

Unless you have time for a full night’s sleep

In children <12 years of age

Right before or after heart surgery

Concomitant administration with any other product containing diphenhydramine, even one used on skin

Experience sleeplessness without pain

Diphenhydramine

• Sedation
• Confusion
• Anticholinergic effects
• May decrease cognitive function in geriatric patients
• Xerostomia
• Pharyngeal and nasal mucosa dryness
• Thick sputum

Ibuprofen

• Nausea
• Vomiting
• Epigastric pain
• Rash
• Edema
• Tinnitus

Asthma (bronchial), cardiac disease, CHF, hepatic/renal impairment, hypertension

Avoid driving or operating machinery

When using this product avoid alcoholic beverages, do not drive motor vehicle or operate machinery, take with food or milk if stomach upset occurs, drowsiness may occur

Diphenhydramine: Caution in narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction

If pregnant or breastfeeding, ask a health professional before use; it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor; it may cause problems in the unborn child or complications during delivery

Ibuprofen

Ask healthcare professional before use; important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a physician because it may cause problems in the unborn child or complications during delivery

Lactation

Ibuprofen

No lactation studies have been conducted; however, limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose; no information is available on effects of ibuprofen on milk production or on a breastfed infant

Diphenhydramine: Enters breast milk; may decrease breast milk production; contraindicated with breastfeeding

NOTE: Do not exceed recommended dosage limits for the specific product prescribed; the following are general guidelines:

diphenhydramine/ibuprofen

Caplet

• 25mg/200mg
• 38mg/200mg