CHILDRENS ALLERGY  - diphenhydramine hydrochloride tablet 
Capricorn Pharma Inc.

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Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 12.5mg

Purpose

Antihistamine

Uses For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

Warnings

Do not use

• with any other product containing Diphenhydramine, even one used on skin
• to make a child sleepy

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 prostate gland

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

When using this product

• Avoid alcoholic beverages
• Marked drowsiness may occur
• Alcohol, sedatives and tranquilizers may increase the drowsiness effect
• Excitability may occur, especially in children
• Be careful when driving a motor vehicle or operating machinery

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Center right away (1-800-222-1222).

Directions

• Take every 4 to 6 hours
• Do not take more than 6 times in 24 hours

Adults and Children 12 years of age and over	2 to 4 tablets
Children 6 to under 12 years of age	1 to 2 tablets
Children under 6 years of age	Consult a doctor
Children under 4 years of age	Do not use

Other Information

• Do not use if carton is opened or blister unit is broken
  
• Store between 20-25°C (68-77°F).  Avoid high humidity. Protect from light.
  
•  See end panel for lot number and expiration date.

Inactive ingredients

aqueous ethyl cellulose dispersion, citric acid, crospovidone, D and C Red # 7 calcium lake, dibasic calcium phosphate, flavor, magnesium stearate, maltodextrin, mannitol, methacrylic acid copolymer, microcrystalline cellulose,  modified food starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triacetin

Principal Display Panel

Capricorn Pharma

ORIGINAL DEVELOPERS AND MANUFACTURERS

NDC 66007-212-02

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ALLERGY FASTMELT

Children's Allergy

Diphenhydramine HCl 12.5mg

ANTIHISTAMINE

Temporarily Relieves:

• Sneezing
• Itchy, Watery Eyes
• Runny Nose
• Itchy Throat

Cherry Flavor

RAPIDMELT
18 Fast Dissolving Tablets

CHILDRENS ALLERGY  diphenhydramine hydrochloride   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 66007-212 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSE   ANHYDROUS CITRIC ACID   CROSPOVIDONE   DIBASIC CALCIUM PHOSPHATE DIHYDRATE   MAGNESIUM STEARATE   MALTODEXTRIN   MANNITOL   METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A   CELLULOSE, MICROCRYSTALLINE   MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)   SILICON DIOXIDE   SODIUM LAURYL SULFATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   SUCRALOSE   TALC   TRIACETIN   AMMONIA   CAPRYLIC/CAPRIC MONO/DIGLYCERIDES   OLEIC ACID

Product Characteristics Color pink Score no score Shape ROUND Size 12mm Flavor CHERRY Imprint Code None Contains

Packaging # NDC Package Description Multilevel Packaging 1 66007-212-02 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK (66007-212-01) 1 66007-212-01 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (66007-212-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/29/2010

Labeler - Capricorn Pharma Inc. (041704524)

Registrant - Capricorn Pharma Inc. (041704524)

Establishment
Name	Address	ID/FEI	Operations
Capricorn Pharma Inc.		041704524	manufacture

Revised: 10/2010Capricorn Pharma Inc.