FDA.reportPublic FDA data

Childrens Allergy Relief

Manufacturer
CalmCo LLC
Effective date
2023-07-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:42

Label at a glance#

ProductChildrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

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 Age (Years) Dose 6-11 years 1-2 Single - Use Vials (5ml each) every 4-6 hours. Do not exceed 12 vials in 24 hours.

Label contents#

Full prescribing information#

Active Ingredient (in each 5mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 12.5mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Do not use

OTC - DO NOT USE SECTION

• to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

Directions

INSTRUCTIONS FOR USE SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Package- 20ct pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

art file of 20ct pouchart file of 20ct pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73282-0125-12024-07-30C16284748780-11e7a6dab-1b5c-a2ce-e063-dadaa90aadf7DrKids Children's Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73282-0125-1Childrens Allergy Relief5 mL in 1 VIAL, SINGLE-DOSESOLUTION53
73282-0125-1Childrens Allergy Relief20 in 1 POUCHSOLUTION203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73282-0125CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE 12.5MG/5ML) SOLUTION [CALMCO LLC]3Legacy NDC, 2 package rows20230722_e8450607-a68c-4729-e053-2995a90a2238.zip

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
73282-012573282-0125-1
70302-127

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
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
010235de-82fd-17f7-e063-6294a90abcd3e8450607-a68c-4729-e053-2995a90a22382023-07-21WarningsExact identifier
spl id: 010235de-82fd-17f7-e063-6294a90abcd3
spl set id: e8450607-a68c-4729-e053-2995a90a2238

Reported adverse events (FAERS/openFDA)#

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