ALLERGY RELIEF CHILDRENS- diphenhydramine hcl solution 
L.N.K. International, Inc.

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Quality Plus 44-015

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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 the child has

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Age (yr)Dose (mL)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years5 mL to 10 mL

Other information

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

Questions or comments?

1-800-426-9391

Principal display panel

QUALITY
+PLUS

NDC 50844-015-19

Compare to active ingredient
in Children’s Benadryl® Allergy*

CHILDREN’S
ALLERGY
RELIEF

Diphenhydramine HCl 12.5 mg
Antihistamine

Relieves
• Sneezing
• Runny nose
• Itchy, Watery eyes
• Itchy throat
or nose

Cherry
Flavor

 8 FL OZ (237 mL)

ALCOHOL FREE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Children’s Benadryl® Allergy.
50844                ORG051901519

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-015

Quality Plus 44-015

ALLERGY RELIEF  CHILDRENS
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-015-191 in 1 CARTON06/28/2024
1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/28/2024
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(50844-015) , pack(50844-015)

Revised: 6/2024
Document Id: b21753dc-1751-46c5-ab51-3f53fefa81f0
Set id: 6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3
Version: 1
Effective Time: 20240628
 
L.N.K. International, Inc.