ALLERGY RAPID MELTS CHILDRENS- diphenhydramine hcl tablet, chewable 
Chain Drug Consortium

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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Premier Value 44-599-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

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

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 doses 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose polymers, magnesium stearate, mannitol, polyethylene and polypropylene polymers, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Principal Display Panel

Premier
Value®

NDC 68016-735-00

*COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S BENADRYL® ALLERGY FASTMELT®

Children's
Allergy Rapid Melts

Diphenhydramine HCl 12.5 mg
ANTIHISTAMINE

Relief for:
• Sneezing        • Itchy throat
• Runny nose    • Itchy, watery eyes

18 Chewable
Tablets

Cherry flavored
rapid melts

INDEPENDANTLY TESTED
PV
SATISFACTION GUARANTEED

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Benadryl® Allergy FastMelt®.
50844                  ORG071259944

DISTRIBUTED BY
CHAIN CONSORTIUM, LLC
UPARC, BLDG. A3, SUITE 338
1020 WILLIAM PITT WAY
PITTSBURGH, PA 15238
www.chaindrugconsortium.com

If for any reason you are not satisfied
with this product, please return it to the
store where purchased for a full refund.

Premier Value 44-599

Premier Value 44-599

ALLERGY RAPID MELTS  CHILDRENS
diphenhydramine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-735
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize12mm
FlavorCHERRYImprint Code 44;599
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-735-003 in 1 CARTON04/25/201104/25/2021
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 FINALpart34104/25/201104/25/2021
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(68016-735)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(68016-735)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(68016-735)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(68016-735)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(68016-735)

Revised: 3/2019
Document Id: 4f53fbaf-876a-447e-a4d3-400a77dd8cf6
Set id: b06d03d1-3d61-4a46-91f4-5e3ad2e8b2b1
Version: 5
Effective Time: 20190320
 
Chain Drug Consortium