FDA.reportPublic FDA data

Childrens Allergy

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2021-01-20
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:10

Label at a glance#

ProductChildrens Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours mL = milliliter  Age (yr) Dose (mL) children under 6 years of age ask a doctor children 6 years to under 12 years of age 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.

Storage and handling

each 5 mL contains: sodium 9 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient [in each 5 mL]

Diphenhydramine HCl, USP 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:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

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

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • sedatives and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • 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

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

Age (yr)
Dose (mL)
children under 6 years of age
ask a doctor
children 6 years to under 12 years of age
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 9 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments? 1-855-274-4122

Distributed ByATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE 

MIAMI, FL 33179

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 17856-0361-01

Compare to
Children's Benadryl®
active ingredient*

Children's
ALLERGY
Antihistamine
diphenhydramine hydrochloride
25mg/10 mL oral solution 
liquid medication

Relieves:

  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat

Sugar & Alcohol Free
Dye-FreeBubble Gum Flavored


image 1image 1

NDC 17856-0361-02

Compare to
Children's Benadryl®
active ingredient*

Children's
ALLERGY

Antihistamine

diphenhydramine hydrochloride
12.5mg/5mL oral solution
liquid medication

Relieves:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat
Sugar & Alcohol Free

Dye-Free
Bubble Gum Flavored

image 2image 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2

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
17856-0361-12023-01-30C16284748780-1f386c64a-3f6a-0266-e053-dadaa90a7c1affd0a29f-370d-4cb1-9b1f-bbcd43f3fc61
17856-0361-22023-01-30C16284748780-1f386c64a-3f6a-0266-e053-dadaa90a7c1affd0a29f-370d-4cb1-9b1f-bbcd43f3fc61

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0361-1Childrens Allergy10 mL in 1 CUP, UNIT-DOSESOLUTION102
17856-0361-1Childrens Allergy72 in 1 BOX, UNIT-DOSESOLUTION722
17856-0361-2Childrens Allergy72 in 1 BOX, UNIT-DOSESOLUTION722
17856-0361-2Childrens Allergy5 mL in 1 CUP, UNIT-DOSESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0361CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 4 package rows20210121_ffd0a29f-370d-4cb1-9b1f-bbcd43f3fc61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-361-26ML - Milliliter46122-3613b93448b-7687-4048-ac19-c7ec234e817a12017-07-07

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-036117856-0361-1, 17856-0361-2
46122-361

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML · Source PDF

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
77d5678c-87ee-4143-a1ae-c2b31b3e547effd0a29f-370d-4cb1-9b1f-bbcd43f3fc612021-01-20WarningsExact identifier
spl id: 77d5678c-87ee-4143-a1ae-c2b31b3e547e
spl set id: ffd0a29f-370d-4cb1-9b1f-bbcd43f3fc61

Reported adverse events (FAERS/openFDA)#

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