FDA.reportPublic FDA data

DrKids Children's Allergy Relief (LA)

Manufacturer
CalmCo LLC
Effective date
2026-07-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
weekly-update
Hydrated at
2026-07-17 21:43:36

Label at a glance#

ProductDr Kids Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves runny nose sneezing itchy, watery eyes due to hay fever itchy nose or throat other upper respiratory allergies

Dosage and administration

do not exceed 12 vials in a 24-hour period follow the “Easy to Use” instructions on pouch Age Dose children 6 to 12 years 1 - 2 vials every 4-6 hours children under 6 years consult a doctor

Label contents#

Full prescribing information#

Active Ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each 5 mL vial)Purpose
Diphenhydramine HCl 12.5 mg...............Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves

  • runny nose
  • sneezing
  • itchy, watery eyes due to hay fever
  • itchy nose or throat
  • other upper respiratory allergies

Warnings

WARNINGS SECTION

.

Do not use

OTC - DO NOT USE SECTION

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • may cause excitability in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed 12 vials in a 24-hour period
  • follow the “Easy to Use” instructions on pouch
AgeDose
children 6 to 12 years 1 - 2 vials every 4-6 hours
children under 6 years consult a doctor

Other information

OTHER SAFETY INFORMATION

  • each 5 mL vial contains: sodium 2 mg
  • store between 68-77°F (20-25°C)
  • do not use if pouch has been torn open or vial is punctured or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol, sucralose, xylitol, water

Questions or comments?

OTC - QUESTIONS SECTION

(M-F) 9AM-5PM EST or visit www.DrKids.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr kids Allergy PDPDr kids Allergy PDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73282-252173282-2521-2, 73282-2521-5, 73282-2521-1, 73282-2521-3, 73282-2521-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
XYLITOLVCQ006KQ1EIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-09-26full-release2026-06-01 01:14:55

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC28ec213e-fabb-28ec-e063-6394a90ad1022026-07-06WarningsExact identifier
ndc (package): 73282-2521-1
ndc (package): 73282-2521-5
ndc (package): 73282-2521-3
ndc (package): 73282-2521-2
ndc (package): 73282-2521-4
ndc (product): 73282-2521
ndc11 (package): 73282252103
ndc11 (package): 73282252105
ndc11 (package): 73282252102
ndc11 (package): 73282252101
ndc11 (package): 73282252104
spl id: 55f40146-b803-36dd-e063-6394a90a020c
spl set id: 28ec213e-fabb-28ec-e063-6394a90ad102

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.