Benadryl

What is Benadryl and how is it used?

Benadryl is a prescription medicine used to treat the symptoms of allergic reactions, insomnia, and motion sickness. Benadryl may be used alone or with other medications.

Benadryl belongs to a class of drugs called Antihistamines, 1st Generation, Antiemetic Agents.

It is not known if Benadryl is safe and effective in children younger than 2 years of age.

What are the possible side effects of Benadryl?

Benadryl may cause serious side effects including:

• pounding heartbeats or fluttering in your chest,
• painful or difficult urination,
• little or no urination,
• confusion,
• lightheadedness,
• tightness in your neck or jaw, and
• uncontrollable movements of your tongue

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Benadryl include:

• dizziness,
• drowsiness,
• loss of coordination,
• dry mouth, nose or throat,
• constipation,
• upset stomach,
• dry eyes,
• blurred vision, and
• day-time drowsiness or feeling "hungover"

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Benadryl. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Benadryl® Allergy contains the histamine-blocker diphenhydramine. This product relieves: runny nose; sneezing; itchy, watery eyes; itchy throat.

Ingredient

Active ingredient (in each capsule)	Purpose
Diphenhydramine HCl 25 mg	Antihistamine

Inactive ingredients

candelilla wax, colloidal silicone dioxide, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, providone, pregelatinized starch, starch, stearic acid, titanium dioxide, and talc

* Effects seen on total nasal symptoms with Benadryl® Allergy (diphenhydramine) 50 mg 3 times daily. Use as directed.

INDICATIONS

Benadryl® Allergy (diphenhydramine) Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing

DOSAGE AND ADMINISTRATION

Directions

• do not use more than directed (see OVERDOSE warning)

adults and children 12 years of age and over	25 mg to 50 mg (1 to 2 capsules).
children 6 to under 12 years of age	12.5 mg ** to 25 mg (1 capsule).
children under 6 years of age	consult a doctor

**12.5 mg dosage strength is not available in Benadryl (diphenhydramine) ® Allergy Kapseals® Capsules.

Other information

• store at 59° to 77°F in a dry place
• protect from light

HOW SUPPLIED

Available in:
Ultratabs® tablets: Box of 24's, 48's, & 100's
Kapseals® capsules: Box of 24's & 48's

FDA rev date: 7/1/1997

SIDE EFFECTS

When using this product:

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machinery

DRUG INTERACTIONS

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

WARNINGS

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

PRECAUTIONS

No information provided.

OVERDOSE

Overdose warning: Taking more than the recommended dose may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

CONTRAINDICATIONS

No information provided.

CLINICAL PHARMACOLOGY

No information provided.

PATIENT INFORMATION

Do not use

• with another product containing any of these active ingredients
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

• heart disease
• glaucoma
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• high blood pressure
• a breathing problem such as emphysema or chronic bronchitis
• cough accompanied by excessive phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

do not use more than directed

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
  

Stop use and ask a doctor if

• redness or swelling is present
• sore throat is severe
• you get nervous, dizzy, or sleepless
• new symptoms occur
• fever gets worse or lasts more than 3 days
• pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
• sore throat lasts for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.

Questions?

call 1-800-524-2624 (English/Spanish), weekdays, 9 AM - 5 PM EST.