ALLERGY RELIEF CHILDRENS- diphenhydramine hcl tablet, chewable

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, 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

• marked drowsiness may occur
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  
• use caution when driving a motor vehicle or operating machinery
• avoid alcoholic beverages
• 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• 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, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-800-426-9391

Principal display panel

Premier
Value®

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

Children's
Allergy Relief

Diphenhydramine HCl 12.5 mg
ANTIHISTAMINE

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

18 Chewable
Tablets

Cherry flavored

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 ORG031759944

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

Premier Value 44-599

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF  CHILDRENS
diphenhydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-051
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)
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	PINK	Score	no score
Shape	ROUND	Size	12mm
Flavor	CHERRY	Imprint Code	44;599
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-051-18	3 in 1 CARTON	04/25/2011
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	04/25/2011

Labeler - Chain Drug Consortium (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(68016-051)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(68016-051)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(68016-051)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(68016-051)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(68016-051)