FDA.reportPublic FDA data

Allergy

Manufacturer
H E B
Effective date
2024-04-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:10:53

Label at a glance#

ProductAllergy Childrens
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in 24 hours take every 4 to 6 hours, or as directed by a doctor measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product find the right dose on chart below  age (yrs) dose (mL)  children 6 to 11 years  5 mL to 10 mL  children 2 to 5 years  do not use unless directed by a doctor  children under 2 years  do not use

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 
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

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

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL = milliliter
  • keep dosing cup with product
  • find the right dose on chart below 
age (yrs)dose (mL)
 children 6 to 11 years 5 mL to 10 mL
 children 2 to 5 years do not use unless directed by a doctor
 children under 2 years do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Protect from light. Store in outer carton until contents are used

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red #33, RD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, and sucrose

Questions or comments?

OTC - QUESTIONS SECTION

 Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Children's Benadryl® Allergy active ingredient*

Children's Allergy Relief

Diphenhydramine HCl, 12.5 mg / Antihistamine

Allergy

For Ages 6 to 11 Years

Alcohol-Free

 Relief of:

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

FL OZ (mL)

CHERRY FLAVOR

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-E-B Children's Allergy Relief
H-E-B Children's Allergy Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN7
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD7
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY7
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY7
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY7

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
37808-012-082023-02-15C16284748780-1f386c64a-3568-0266-e053-dadaa90a7c1aDrug Facts
37808-012-082023-01-30C16284748780-1f386c64a-3568-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-012-08AllergyChildrens1 in 1 BOXLIQUID17
37808-012-08AllergyChildrens237 mL in 1 BOTTLE, PLASTICLIQUID2377

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-012ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [H E B]7Current NDC, Legacy NDC, 2 package rows20240410_ab28cbc4-7a6f-46e9-8616-be78e8cb24fe.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
37808-01237808-012-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCROSEC151H8M554IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT

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
Allergy ChildrensDIPHENHYDRAMINE HYDROCHLORIDEH E Bab28cbc4-7a6f-46e9-8616-be78e8cb24fe2024-04-08WarningsExact identifier
ndc (package): 37808-012-08
ndc (product): 37808-012
ndc11 (package): 37808001208
spl id: 9e60c1a8-4250-402a-8cd8-cb77b9b576ba
spl set id: ab28cbc4-7a6f-46e9-8616-be78e8cb24fe

Reported adverse events (FAERS/openFDA)#

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