FDA.reportPublic FDA data

Childrens Allergy Relief

Manufacturer
Allegiant Health
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:18

Label at a glance#

ProductChildrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

do not take more than directed do not take more than 6 doses in 24 hours mL = milliliter only use the dosing cup provided find right dose on chart below take every 4 to 6 hours, or as directed by a doctor    children under 2 years:  do not use    children 2 to 5 years:  do not use unless directed by a doctor children 6 to 11 years:  5 mL to 10 mL

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg in each 5ml

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use(s)

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

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

the child is taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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)

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • do not take more than 6 doses in 24 hours
  • mL = milliliter
  • only use the dosing cup provided
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor 
  •  
  • children under 2 years: do not use 
  •  
  • children 2 to 5 years: do not use unless directed by a doctor

children 6 to 11 years: 5 mL to 10 mL

Other information

SPL UNCLASSIFIED SECTION

each 5 ml contains: sodium 4 mg 

store at 25°C (77°F); excursions permitted between 15-30°C (59°-86°F)

see end flap lot expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium
benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday Through Friday 9AM – 5PM EST.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy ReliefAllergy ReliefChildren's Allergy LabelChildren's Allergy Label

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-471-59Childrens Allergy Relief1 in 1 CARTONLIQUID13
69168-471-59Childrens Allergy Relief237 mL in 1 BOTTLELIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-471CHILDRENS ALLERGY RELIEF LIQUID [ALLEGIANT HEALTH]3Current NDC, 2 package rows20250215_cb6df361-b8e5-4e2f-945f-c20159d76c4f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-47169168-471-59

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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
Childrens Allergy ReliefCHILDRENS ALLERGY RELIEFAllegiant Healthcb6df361-b8e5-4e2f-945f-c20159d76c4f2025-01-06WarningsExact identifier
ndc (package): 69168-471-59
ndc (product): 69168-471
ndc11 (package): 69168047159
spl id: 00634319-dc1f-442f-a4f4-1c0a4c6c58da
spl set id: cb6df361-b8e5-4e2f-945f-c20159d76c4f

Reported adverse events (FAERS/openFDA)#

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