CHILDRENS ALLERGY- diphenhydramine hydrochloride tablet

Childrens Allergy by

Drug Labeling and Warnings

Childrens Allergy by is a Otc medication manufactured, distributed, or labeled by Capricorn Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Diphenhydramine HCl 12.5mg

Purpose

Antihistamine

INDICATIONS & USAGE

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

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY 
diphenhydramine hydrochloride tablet

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CROSPOVIDONE (UNII: 68401960MK)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)
AMMONIA (UNII: 5138Q19F1X)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
OLEIC ACID (UNII: 2UMI9U37CP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66007-212-02	3 in 1 CARTON
1	NDC: 66007-212-01	6 in 1 BLISTER PACK

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	Business Operations
Capricorn Pharma Inc.		041704524	manufacture