CHILDRENS ALLERGY RELIEF- diphenydramine hcl tablet, chewable

Childrens Allergy Relief by

Drug Labeling and Warnings

Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 years: 1 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

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 - ANTIHISTAMINE

Relief of:

Sneezing 
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

18 CHEWABLE
     TABLETS

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    ORG031758544

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0218
QUESTIONS? 1-888-423-0139

topcare@topco.com    www.topcarebrand.com

TopCare 44-585

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-585
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)

Product Characteristics
Color	PURPLE	Score	no score
Shape	ROUND	Size	12mm
Flavor	GRAPE	Imprint Code	44;585
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-585-44	3 in 1 CARTON	03/20/2009
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/20/2009

Labeler - Topco Associates, LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(36800-585)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(36800-585)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(36800-585)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(36800-585)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(36800-585)