Diphenhydramine Oral Solution

Name: Diphenhydramine Oral Solution

Diphenhydramine May Interact with Other Medications

Do not take this medicine with any of the following medications:

  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

  • alcohol
  • barbiturates like phenobarbital
  • medicines for bladder spasm like oxybutynin, tolterodine
  • medicines for blood pressure
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for movement abnormalities or Parkinson's disease
  • medicines for sleep
  • other medicines for cold, cough, or allergy
  • some medicines for the stomach like chlordiazepoxide, dicyclomine
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

How to Use diphenhydramine

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Use a specially marked spoon or container to measure your medicine. Household spoons are not accurate. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • glaucoma
  • high blood pressure or heart disease
  • liver disease
  • lung or breathing disease, like asthma
  • pain or trouble passing urine
  • prostate trouble
  • ulcers or other stomach problems
  • an unusual or allergic reaction to diphenhydramine, other medicines foods, dyes, or preservatives such as sulfites
  • pregnant or trying to get pregnant
  • breast-feeding
What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.

If you are diabetic use a sugar-free form of this medicine.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature, between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light and moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

Diphenhydramine Oral Solution - Clinical Pharmacology

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours. Diphenhydramine is widely distributed throughout the body, including the CNS. Little, if any, is excreted unchanged in the urine; most appears as the degradation products of metabolic transformation in the liver, which are almost completely excreted within 24 hours.

Adverse Reactions

The most frequent adverse reactions are underscored.

  1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose and throat.
  2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles.
  3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
  4. Nervous System: Sedation,sleepiness,dizziness,disturbedcoordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.
  5. GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
  6. GU System: Urinary frequency, difficult urination, urinary retention, early menses.
  7. Respiratory System: Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness.

How is Diphenhydramine Oral Solution Supplied

Each 5 mL of Diphenhydramine Hydrochloride Oral Solution USP (purple/red color, cinnamon/anise flavor) contains 12.5 mg diphenhydramine hydrochloride with 14% alcohol and is supplied in the following oral dosage forms:

NDC 0121-0489-05:  5mL unit dose cup

NDC 0121-0489-00:  Case contains 100 unit dose cups of 5mL (0121-0489-05) packaged in 10  trays of 10 unit dose cups each.

NDC 0121-0978-10:  10mL unit dose cup

NDC 0121-0978-00:  Case contains 100 unit dose cups of 10mL (0121-0978-10) packaged in 10  trays of 10 unit dose cups each. 

Pharmaceutical Associates, Inc.
Greenville, SC 29605

www.paipharma.com

R10/16

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