CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride solution 
CalmCo LLC

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DrKids Children's Allergy Relief

DRUG FACTS

Active Ingredient (in each 5mL)

Diphenhydramine HCL 12.5mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • 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 your child has

• a breathing problem such as chronic bronchitis

• glaucoma

• a sodium-restricted diet

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 (1-800-222-1222)

Directions

  • this product does not contain directions or complete warnings for adult use
  • give the recommended number of vials below following the instructions under Easy to Use on the side panel
  • do not take more than 6 doses in any 24 hour period
  • empty each Single-Use Vial of all liquid when dosing

Dosing Chart

Age (Years)Dose
6 - 11 years1 - 2 Single-Use Vials (5mL each) every 4-6 hours. Do not exceed 12 vials in 24 hours

Inactive ingredients

citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, tri-sodium citrate, xanthan gum

Other information

  • each Single-Use vial contains 16mg of sodium
  • store at 68-77ºF (20-25ºC)
  • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken

Questions or comments?

941-202-3270 or visit www.DrKids.com

Package

PDP

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0012
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
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-0012-120 in 1 CARTON08/06/2021
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/06/2021
Labeler - CalmCo LLC (079308308)

Revised: 12/2023
Document Id: 0c94060a-bddd-6ceb-e063-6394a90a745f
Set id: c8ea4c6d-19c7-894f-e053-2a95a90a30af
Version: 4
Effective Time: 20231215
 
CalmCo LLC