CHILDRENS ALLERGY RELIEF- diphenhydramine hcl tablet, chewable 
Topco Associates, LLC

----------

TopCare 44-585

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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 right away.

Directions

 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

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

Questions or comments?

1-888-423-0139

Principal Display Panel

+TopCare®
         
health

NDC 36800-585-44

COMPARE TO CHILDREN'S BENADRYL® CHEWABLES ACTIVE INGREDIENT*

children's
Allergy Relief

DIPHENHYDRAMINE HCl 12.5 mg
CHEWABLE TABLETS - ANTIHISTAMINE

4-6
HOURS/
DOSE

 RELIEF OF:

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

18 CHEWABLE
     TABLETS

Chew or crush tablets completely before swallowing.

For Ages 6 to 11 Years

GRAPE
FLAVOR

actual size

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 Children's Benadryl® Chewables.

50844   REV1218B58544

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0521
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com

QUALITY
GUARANTEED

Topcare 44-585

Topcare 44-585

CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-585
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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorpurpleScoreno score
ShapeROUNDSize12mm
FlavorGRAPEImprint Code 44;585
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-585-443 in 1 CARTON03/20/2009
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 DrugM01203/20/2009
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(36800-585)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(36800-585)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(36800-585)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(36800-585)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(36800-585)

Revised: 7/2023
Document Id: e6676031-18a6-4eb0-8241-737ed68d1591
Set id: bfcabe02-7961-4407-a748-8cd087731398
Version: 9
Effective Time: 20230720
 
Topco Associates, LLC