DIPHENHYDRAMINE HYDROCHLORIDE  - diphenhydramine hydrochloride tablet, coated 
New World Imports, Inc

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Drug Facts

Diphenhydramine HCI 25 mg

Antihistamine

In case of overdose, get medical help or contact a Poison Control Center right away.

Temporarily relieves these symptoms of the common cold: runny nose and sneezing.

Temporarily relieves symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy nose or throat, itchy, watery eyes.

Do not use with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have:

A breathing problem such as emphysema or chronic bronchitis

Glaucoma

Difficulty in urination due to an enlargement of the prostate gland

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

When using this product:

Excitability may occur especially in children

Drowsiness may occur

Avoid alcoholic drinks

Alcohol, sedatives, and tranquilizers may increase drowsiness

Use caution when operating machinery or driving a motor vehicle

If pregnant or breast-feeding,ask a health professional  before use.

Take every 4 to 6 hours, not more than 6 doses in 24 hours.

Adults and children 12 years of age and over: Take 1 or 2 tablets

Children 6 to under 12 years of age: Take 1 tablet

Children under 6 years of age: Consult a doctor

Children under 4 years of age:do not use

Carnauba wax, colloidal silicon dioxide croscarmellose sodium, D and C Red No 27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcyrstalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80 and titanium dioxide.  May also contain: polyvinyl alcohol and talc.

DIPHENHYDRAMINE HYDROCHLORIDE  diphenhydramine hydrochloride   tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 51824-025 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diphenhydramine Hydrochloride (Diphenhydramine ) Diphenhydramine Hydrochloride 25 mg

Inactive Ingredients Ingredient Name Strength Carnauba Wax   Colloidal Silicon Dioxide   Croscarmellose Sodium   D&C RED NO. 27   Dibasic Calcium Phosphate Dihydrate   HYPROMELLOSES   Magnesium Stearate   Cellulose, Microcrystalline   Polyethylene Glycol 400   Polysorbate 80   Titanium Dioxide   Polyvinyl Alcohol   Talc

Product Characteristics Color pink (Pink) Score no score Shape OVAL (Oval) Size 14mm Flavor Imprint Code 25;V Contains

Packaging # NDC Package Description Multilevel Packaging 1 51824-025-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/11/2010

Labeler - New World Imports, Inc (075372276)

Revised: 11/2010New World Imports, Inc