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Childrens Allergy Relief by Topco Associates, LLC

Medically reviewed on January 19, 2018

Dosage form: tablet, chewable
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg
Labeler: Topco Associates, LLC
NDC Code: 36800-585

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.

Topcare 44-585

Active ingredient (in each chewable 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
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages
  • marked drowsiness may occur
  • 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 (1-800-222-1222) right away.

Directions
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
 Age (yr)Dose (chewable tablets)
children under 2 years
do not use
children 2 to 5 years   
do not use unless
directed by a doctor
children 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12  years and over     
2 to 4 chewable tablets (25 mg to 50 mg)

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Principal Display Panel

NDC 36800-585-44

CHEWABLE TABLETS

Children's
Allergy Relief

DIPHENHYDRAMINE HCl
ANTIHISTAMINE

Relief of:

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

18 TABLETS

Grape Flavored

COMPARE TO CHILDREN'S BENADRYL® CHEWABLES active ingredient*

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark

50844    REV0317A58544

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNK817
QUESTIONS? 1-888-423-0139

topcare@topco.com    www.topcarebrand.com

TopCare 44-585

CHILDRENS ALLERGY RELIEF 
diphenydramine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-585
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
D&C RED NO. 30 
ETHYLCELLULOSES 
FD&C BLUE NO. 1 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MANNITOL 
STEARIC ACID 
SUCRALOSE 
SUCROSE 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize12mm
FlavorGRAPEImprint Code44;585
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-585-443 BLISTER PACK in 1 CARTON
16 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/20/2009
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(36800-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(36800-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(36800-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(36800-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(36800-585)

 
Topco Associates, LLC

← See all Childrens Allergy Relief brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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