CHILDRENS ALLERGY RELIEF- diphenhydramine hcl tablet, chewable

Childrens Allergy Relief by

Drug Labeling and Warnings

Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, 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

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

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
• avoid alcoholic beverages
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution 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 (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, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-888-287-1915

Principal Display Panel

NDC: 49035-599-09

equate™

Compare
to Children's
Benadryl®
Chewables Active
Ingredient*

Children's
ALLERGY RELIEF
Diphenhydramine HCl, 12.5 mg
Antihistamine

6 YEARS AND OLDER

Relief of:
Sneezing         Runny nose  
Itchy throat or nose
Itchy, watery eyes

Cherry Flavored

20 CHEWABLE TABLETS

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                REV0317A59909

DISTRIBUTED BY: Wal-mart stores, Inc., Bentonville, AR 72716

Satisfaction guaranteed - Or we'll replace it or
give you your money back. For questions or
comments or to report an undesired reaction
or side effect, please call 1-888-287-1915.

Equate 44-599

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-599
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 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
SUCROSE (UNII: C151H8M554)

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: 49035-599-44	3 in 1 CARTON	04/25/2011
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49035-599-09	4 in 1 CARTON	04/25/2011
2		5 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 - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(49035-599)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(49035-599)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(49035-599)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(49035-599)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(49035-599)