Target 44-599

Drug Labeling and Warnings

Drug Details [pdf]

CHILDRENS ALLERGY MELTS- diphenhydramine hcl tablet, chewable 
Target Corporation

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.

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Target 44-599

Active ingredient (in each 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 products 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
• trouble urinating due to an enlarged 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 drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful 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 right away.

Directions

• dissolve in mouth or chew before swallowing
• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours

• children under 2 years of age: do not use
• children 2 to under 6 years of age:

  do not use unless ; directed by a doctor

• children 6 to under 12 years of age: 1 to 2 tablets
• adults and children 12 years of ageand over: 2 to 4 tablets

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose polymers, magnesium stearate, mannitol, polyethylene and polypropylene polymers, stearic acid, sucralose

Questions?

 Call 1-800-910-6874

Principal Display Panel

NDC: 11673-599-44

Compare to active ingredient in Children's Benadryl® Allergy FastMelt® Tablets*

children's allergy melts
diphenhydramine HCl, 12.5 mg
antihistamine
for relief of sneezing/runny nose/
itchy throat/itchy, watery eyes
dissolving tablets melt in your mouth

18 DISSOLVING TABLETS

CHERRY FLAVOR

18 TABLETS

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

094 04 0094   ID241423
Distributed by Target Corporation, Minneapolis, MN 55403
©2013 Target Brands, Inc.
All Rights Reserved    Shop Target.com

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Benadryl® Allergy FastMelt® Tablets.

50844        REV0712A59944

Target 44-599

CHILDRENS ALLERGY MELTS 
diphenhydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-599
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)
CHERRY (UNII: BUC5I9595W)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STEARIC ACID (UNII: 4ELV7Z65AP)

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: 11673-599-44	3 in 1 CARTON	04/25/2011	08/04/2019
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	08/04/2019

Labeler - Target Corporation (006961700)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(11673-599)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(11673-599)

Revised: 8/2016

Document Id: ed128653-9e87-42dd-b8cd-25aa79c73a5c

Set id: b1bca0b6-e3c1-4d4c-9838-ad56b327652a

Version: 5

Effective Time: 20160829