FDA.reportPublic FDA data

childrens allergy relief

Manufacturer
Target Corporation | LNK International, Inc.
Effective date
2025-03-12
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 00:57:21

Label at a glance#

Productchildrens allergy relief dye-free
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed find right dose on chart below mL = milliliter only use the dose cup provided 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

Storage and handling

each 5 mL contains: sodium 4 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

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:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • 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 the child has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma

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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided
  • 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

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 4 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for 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?

OTC - QUESTIONS SECTION

Call 1-800-910-6874

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11673-817-19

Compare to active
ingredient in Children's
Benadryl® Allergy*

dye-free
Children's
 allergy
 relief

diphenhydramine HCl, 12.5 mg
per 5 mL oral solution/antihistamine

alcohol and sugar free

for relief of:
• runny nose
• sneezing
• itchy, watery eyes
• itchy throat or nose

up & up™

CHERRY
FLAVOR

AGES
6-11
YEARS

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Children’s Benadryl® Allergy.
50844 REV0123B01719

Distributed by Target Corporation
Minneapolis, MN 55403
TM & ©2023 Target Brands, Inc.

Target 44-017
Target 44-017

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
11673-817-19childrens allergy reliefdye-free237 mL in 1 BOTTLE, PLASTICSOLUTION23716
11673-817-19childrens allergy reliefdye-free1 in 1 CARTONSOLUTION116
11673-817-36childrens allergy reliefdye-free1 in 1 CARTONSOLUTION116
11673-817-36childrens allergy reliefdye-free118 mL in 1 BOTTLESOLUTION11816

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-817CHILDRENS ALLERGY RELIEF DYE-FREE (DIPHENHYDRAMINE HCL) SOLUTION [TARGET CORPORATION]16Legacy NDC, 4 package rows20250321_5f66b48b-8196-4ad5-ab85-c6fd0fa66cbc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-817-36ML - Milliliter11673-8176eb80b05-aa43-435b-910f-a7fe471ca66312020-02-13

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
11673-81711673-817-19, 11673-817-36

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
e8385971-d4a6-48c2-862e-9d3c39be34e75f66b48b-8196-4ad5-ab85-c6fd0fa66cbc2025-03-12WarningsExact identifier
spl id: e8385971-d4a6-48c2-862e-9d3c39be34e7
spl set id: 5f66b48b-8196-4ad5-ab85-c6fd0fa66cbc

Reported adverse events (FAERS/openFDA)#

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