Premier Value 44-599-Childrens

Premier Value 44-599-Childrens

Drug Labeling and Warnings

Drug Details

k">

ALLERGY RELIEF CHILDRENS- diphenhydramine hcl tablet, chewable 
Chain Drug Consortium

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.

----------

Premier Value 44-599-Childrens

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 yearsdo not use
children 2 to 5 yearsdo 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

  • 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

Premier Value 44-599

ALLERGY RELIEF  CHILDRENS
diphenhydramine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68016-051
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)  
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)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize12mm
FlavorCHERRYImprint Code 44;599
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68016-051-183 in 1 CARTON04/25/2011
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 FINALpart34104/25/2011
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(68016-051)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(68016-051)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(68016-051)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(68016-051)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(68016-051)

Revised: 3/2019
 
Chain Drug Consortium


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.