PREFERRED PLUS COMPLETE ALLERGY MEDICINE - diphenhydramine hydrochloride capsule 
Kinray 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 banded capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
Temporarily relieves these symptoms due to the common cold

Warnings


Do not use

  • With any other product containing Diphenhydramine even one used on skin

Ask a doctor before use if you have

  • Glaucoma
  • A breathing problem such as emphysema or chronic bronchitis
  • Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions

Adults and children 12 years of age and over

1 to 2 capsules                                  

Children 6 to under 12 years of

age

1 capsule

Children under 6 years of ageask a doctor

Other information

Inactive ingredients

D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

Questions?

Adverse drug event call: (866) 562-2756

Principal Display Panel

Complete Allergy Medicine
Antihistamine
Diphenhydramine HCl 25mg
For the temporary relief of:

Blocks Histamine
*Compare to the Active Ingredient in Benadryl®.
Safety Sealed Capsules
*This product is not manufactured or distributed by McNeail Consumer Healthcare, owner of the registered trademark Benadryl®. All Preferred Plus Pharmacy are satisfaction guaranteed or your money back from retailer where purchased.
Distributed By: Kinray, Inc.
Whitestone, NY 11357

©2013 Kinray, Inc., All rights reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks of Kinray, Inc. All other marks are property of their respective owners.
Product Label

Preferred Plus Complete Allergy Releif product label

PREFERRED PLUS COMPLETE ALLERGY MEDICINE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-055
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH;014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-055-511 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
2NDC:61715-055-242 in 1 CARTON
212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/07/2013
Labeler - Kinray Inc. (012574513)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(61715-055) , pack(61715-055) , label(61715-055)

Revised: 5/2013
Document Id: cf1eef15-fff0-4590-b602-cf28fbe967f8
Set id: 862c63e7-9eba-4fb4-9286-37079b66d7a0
Version: 1
Effective Time: 20130502
 
Kinray Inc.