Adult Dosing
For reducing pain/inflammation, fever and promoting sleep
- 2 tabs/caps PO qhs PRN with food; Max: 2 tabs or caps/day
Notes:- For tablets, diphenhydramine citrate 38 mg is equivalent to 25 mg diphenhydramine
- Use lowest effective dose for shortest effective duration
Pediatric Dosing
For reducing pain/inflammation, fever and promoting sleep
- Children
12 yrs: 2 tabs/caps PO qhs PRN with food; Max: 2 tabs or caps/day
Notes:- For tablets, diphenhydramine citrate 38 mg is equivalent to 25 mg diphenhydramine
- Use lowest effective dose for shortest effective duration
[Outline]
See Supplemental Patient Information
- Do not exceed recommended dosage or consume for a longer time than directed
- Therapy may cause severe allergic reactions manifested as hives, facial swelling, asthma, shock, erythema, rash, and blisters, particularly in people allergic to aspirin. Discontinue therapy if an allergic reaction occurs
- NSAIDs may cause severe stomach bleeding, especially in patients >60 yrs of age, with stomach ulcers or bleeding problems, consuming 3 or more alcoholic drinks a day during therapy, and those receiving concomitant anticoagulant or steroid therapy. Concomitant use of other drugs containing NSAIDs also increases the risk of stomach bleeding
- Avoid use of this combination drug in children <12 years of age, patients with an allergic reaction to any other pain reliever/fever reducer, and in those immediately before or after heart surgery
- Avoid use in patients who do not have time for a full night's sleep, receiving any other medication containing diphenhydramine, even the one applied on skin, and in those having sleeplessness without pain
- Advise patients to consult their physician before using therapy in case of stomach bleeding, history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, glaucoma, asthma, emphysema, chronic bronchitis, diabetes or trouble urinating
- Advise patients to inform their clinician if they are being treated with sedatives or tranquilizers or any other antihistamines; or if they are under a primary care for any continuing medical illness
- Ibuprofen may decrease the therapeutic benefit of aspirin for heart attack or stroke. Instruct patients taking aspirin to consult their physician before therapy use
- Significant drowsiness may occur during therapy; avoid concomitant use of alcoholic beverages, alcohol, sedatives and tranquilizers as they may worsen drowsiness. Advise patients to avoid driving a motor vehicle or operating machinery
- Instruct patients to take this combination drug with food or milk if stomach upset develops
- Increased risk of heart attack or stroke may be seen in patients using this medication for a prolonged time or in doses more than directed
- Discontinue therapy and promptly consult a physician if the patient experiences fainting, hematemesis, bloody or black stools, and worsening stomach pain. Also, discontinue therapy if new symptoms occur, redness or swelling is noted in the painful area, pain gets worse or lasts >10 days, or if sleeplessness lasts >2 wks; further evaluate the patients as these could be signs of a serious underlying medical condition
- Avoid therapy use during the last 3 months of pregnancy unless definitely directed to do so by a clinician as it may cause problems in the unborn child or may induce complications during delivery
- Instruct patients to immediately contact a Poison Control Center in case of overdose
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- CHF
- Hypertension
- Cardiac disease risk
- Cardiovascular disease
- GI obstruction
- Prostatic hypertrophy
- Bladder neck obstruction
- Peptic ulcer disease
- History of GI bleed
- Fluid retention
- Dehydration
- Asthma
- COPD
- Coagulation disorder
- Chronic use of alcohol
- Prolonged use
- Smokers
- Debilitated patients
- Increased IOP
- Angle-closure glaucoma
- Hyperthyroidism
- CNS depressant use
- Pediatric population
- Geriatric population
- Lower respiratory tract symptoms
- Poor CYP2D6 metabolizer
- High environmental temperature
Supplemental Patient Information
- Instruct patients undergoing treatment to exercise caution while driving a motor vehicle or operating machinery
- Advise women of childbearing potential to stop use of this combination drug if they are pregnant, breastfeeding, or having intention of becoming pregnant
- Inform patients to keep this drug out of reach of children
- Instruct patients to avoid alcoholic beverages during therapy
Pregnancy Category:NR
Breastfeeding: Small, occasional doses of diphenhydramine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause effects in the infant or decrease the milk supply, particularly when used in combination with a sympathomimetic agent or when lactation is not well established. The nonsedating antihistamines are preferred alternatives. Ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers, because of its low levels in breastmilk, short half-life, and use in infants in doses much higher than those excreted in breastmilk. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 12 March 2012). Manufacturer advises to consult a healthcare professional.
US Trade Name(s)
US Availability
diphenhydramine/ibuprofen (generic)
- OTC TABS: 38 mg/200 mg
- OTC CAPS: 25 mg/200 mg
Advil PM, Motrin PM (diphenhydramine/ibuprofen)
Advil PM (diphenhydramine/ibuprofen)
Canadian Trade Name(s)
- Advil Cold & Flu
- Advil Nighttime
Canadian Availability
Advil Cold & Flu (diphenhydramine/ibuprofen)
Advil Nighttime (diphenhydramine/ibuprofen)
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
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