FDA.reportPublic FDA data

CareOne Childrens Allergy Relief

Manufacturer
American Sales Company
Effective date
2024-07-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:15:54

Label at a glance#

ProductCareOne Childrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itching of the nose or throat • runny nose • itchy, watery eyes

Dosage and administration

• find right dose on chart below • mL = milliliter • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours Age (yr) Dose (mL) 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 Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing ...

Storage and handling

• each 5 mL contains: sodium 15 mg • store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used. • do not use if printed neckband is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itching of the nose or throat
    • runny nose
    • itchy, watery eyes

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness

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

  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

Age (yr)

Dose (mL)

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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 15 mg
  • store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if printed neckband is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREone®

Compare to the active ingredient in Children’s Benadryl® Allergy Liquid

For Ages 6 to 11 Years

Children’s Allergy Relief

Diphenhydramine HCl 12.5 mg/5 mL Oral Solution

Antihistamine

dosage cup included

Cherry Flavored

RELIEF OF:

• Runny Nose

• Sneezing

• Itchy, Watery Eyes

• Itchy Throat or Nose

• 4-6 Hours/Dose

• Alcohol Free

• Gluten Free

4 FL OZ (118mL)

Children's Allergy Relief Cherry Carton Image
Children's Allergy Relief Cherry Carton Image

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
41520-632-262024-01-30C16284748780-11030e365-43b8-111a-e063-dadaa90a10e2American Sales Company Children’s Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-632-26CareOne Childrens Allergy Relief1 in 1 CARTONSOLUTION13
41520-632-26CareOne Childrens Allergy Relief118 mL in 1 BOTTLESOLUTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-632CAREONE CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [AMERICAN SALES COMPANY]3Current NDC, Legacy NDC, 2 package rows20240724_bb78ef2c-4f42-4e8f-b38d-f9b2965a384b.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-63241520-632-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL SOLUTION8KW3E207O2IACT
GLYCERINPDC6A3C0OXIACT

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
CareOne Childrens Allergy ReliefDIPHENHYDRAMINE HCLAmerican Sales Companybb78ef2c-4f42-4e8f-b38d-f9b2965a384b2024-07-19WarningsExact identifier
ndc (package): 41520-632-26
ndc (product): 41520-632
ndc11 (package): 41520063226
spl id: 1f193443-00a7-4f02-89fe-bb9035328602
spl set id: bb78ef2c-4f42-4e8f-b38d-f9b2965a384b

Reported adverse events (FAERS/openFDA)#

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