CHILDRENS ALLERGY - diphenhydramine hydrochloride tablet 
Capricorn Pharma Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Adults and Children 12 years of age and over2 to 4 tablets
Children 6 to under 12 years of age1 to 2 tablets
Children under 6 years of ageConsult a doctor
Children under 4 years of ageDo not use

Other Information

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:

Cherry Flavor

RAPIDMELT
18 Fast Dissolving Tablets

Diphenhydramine HCl Antihistamine carton

CHILDRENS ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66007-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeROUNDSize12mm
FlavorCHERRYImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66007-212-023 in 1 CARTON
1NDC:66007-212-016 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/29/2010
Labeler - Capricorn Pharma Inc. (041704524)
Registrant - Capricorn Pharma Inc. (041704524)
Establishment
NameAddressID/FEIBusiness Operations
Capricorn Pharma Inc.041704524manufacture

Revised: 10/2010
Document Id: 557a995c-3fe4-411c-94ef-f6d4f1bd0a55
Set id: 327ccd2d-dcc6-4919-83d7-51d8920b7b01
Version: 1
Effective Time: 20101004
 
Capricorn Pharma Inc.