FDA.reportPublic FDA data

DrKids Allergy Gummies (AFL)

Manufacturer
CalmCo LLC
Effective date
2026-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:36:26

Label at a glance#

ProductDr Kids Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

■ do not exceed 12 chewables in a 24-hour period ■ chew thoroughly before swallowing Age Dose (chew) children 6 to 12 years and older take 1-2 chewables every 4 to 6 hours children under 6 years consult a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

_________

Active Ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

Active ingredient (in each chew)Purpose
Diphenhydramine HCl 12.5 mg...............Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves

■ runny nose

■ sneezing

■ itchy nose or throat

■ itchy, watery eyes due to hay fever

■ 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

■ is 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 chewables in a 24-hour period

■ chew thoroughly before swallowing

AgeDose (chew)
children 6 to 12 years and oldertake 1-2 chewables every 4 to 6 hours
children under 6 yearsconsult a doctor

Other information

OTHER SAFETY INFORMATION

■ store between 68-77°F (20-25°C)

■ avoid high humidity and protect from light

■ do not use if foil seal under cap is torn, broken or missing

■ see bottom of bottle for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

beta-cyclodextrin, carrageenan, corn syrup, flavors, purified water, sucrose, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

+1-941-203-4509 (M-F) 9 AM - 5 PM EST or www.calmco.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy 20ct FTAllergy 20ct FTAllergy 20ct BerryAllergy 20ct Berry

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73282-253073282-2530-1
73282-253173282-2531-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
BETADEXJV039JZZ3AIACT
WATER059QF0KO0RIACT
CARRAGEENAN5C69YCD2YJIACT
CORN SYRUP9G5L16BK6NIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SUCROSEC151H8M554IACT
SUCRALOSE96K6UQ3ZD4IACT
BETADEXJV039JZZ3AIACT
WATER059QF0KO0RIACT
CARRAGEENAN5C69YCD2YJIACT
CORN SYRUP9G5L16BK6NIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SUCROSEC151H8M554IACT

Source Document#

Source XML

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 LLC5533e705-b8d5-71cf-e063-6394a90a20102026-06-26WarningsExact identifier
ndc (package): 73282-2530-1
ndc (package): 73282-2531-1
ndc (product): 73282-2530
ndc (product): 73282-2531
ndc11 (package): 73282253101
ndc11 (package): 73282253001
spl id: 5533e705-b8d4-71cf-e063-6394a90a2010
spl set id: 5533e705-b8d5-71cf-e063-6394a90a2010

Reported adverse events (FAERS/openFDA)#

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