Special Alerts:
[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough and http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.
| Benadryl Ultratab | |||
| Diphenhist | |||
| DiphenhydrAMINE Hydrochloride | |||
Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine and talk to your doctor if you experience
sleepiness, fatigue, or dizziness;
headache;
dry mouth; or
difficulty urinating or an enlarged prostate.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These products may contain medicines similar to diphenhydramine, which could lead to an antihistamine overdose.
Before taking this medication, tell your doctor if you are taking any of the following medicines:
anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);
medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or
any other medications that make you feel drowsy, sleepy, or relaxed.
Drugs other than those listed here may also interact with diphenhydramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
Your pharmacist has more information about diphenhydramine written for health professionals that you may read.
Diphenhydramine is available with a prescription and over the counter generically and under many brand names as tablets, capsules, an elixir, and a syrup. Other formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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