CHILDRENS ALLERGY- diphenhydramine hcl tablet, chewable 
L&R Distributors, 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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Select Brand 44-585 Delisted

Active ingredient (in each tablet)

Diphenhydramine HCl 12.5 mg 

Purpose

Antihistamine 

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat 

Warnings

Do not use

  • to make a child sleepy
  • 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
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 Control Center right away. 

Directions

  • dissolve in mouth or chew before swallowing
  • take every 4 to 6 hours
  • do not take more than 6 doeses in 24 hours
children under 2 years of age do not use 
children 2 to under 6 years of age do not use unless
directed by a doctor 
children 6 to under 12 years of age 1 to 2 tablets 
adults and children 12 years of age
and over 		 2 to 4 tablets

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose polymers, FD&C blue #1 aluminum lake, grape flavor art #554, magnesium stearate, mannitol, polyethylene and polypropylene polymers, stearic acid, sucralose

Questions or comments?

Call 1-800-426-9391

Principal display panel

NDC 15127-863-18

select brand®
the lower price name brand

CHILDREN'S
ALLERGY
DIPHENHYDRAMINE HCl 12.5 mg TABLETS • ANTIHISTAMINE

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

RAPIDMELT™
GRAPE

*Compare to the Active Ingredient of Children's Benadryl® Allergy FastMelt®

18 Dissolving Tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children"s Benadryl® Allergy FastMelt®.
50844    ORG051258544

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Select Brand 44-585

Select Brand 44-585

CHILDRENS ALLERGY 
diphenhydramine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-863
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
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTRATES (UNII: G263MI44RU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code 44;585
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-863-183 in 1 CARTON
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/20/200905/16/2017
Labeler - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(15127-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(15127-863)

Revised: 3/2016
Document Id: a22dbd64-247d-4d10-b774-cf7ef3044475
Set id: f8320fd1-4f24-42e4-99b0-45200b9fbe82
Version: 2
Effective Time: 20160315
 
L&R Distributors, Inc.