FDA.reportPublic FDA data

Goodsense Childrens Allergy Relief Dye Free 549

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER | Guardian Drug Company
Effective date
2024-10-21
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:27:44

Label at a glance#

ProductChildrens Allergy Relief Dye Free
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Dosage and administration

take every 4 to 6 hours  do not take more than 6 doses in 24 hours  use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device AGE(yr) DOSE(mL or tsp)   children under 2 years   do not use  children 2 to under 6 years   ask a doctor  children 6 to under 12 years   1 to 2 tsp (5 mL to 10 mL)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

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
  • 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

  • glaucoma 
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

  • alcohol, 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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours 
  • do not take more than 6 doses in 24 hours 
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device


AGE(yr)DOSE(mL or tsp) 
 children under 2 years  do not use
 children 2 to under 6 years  ask a doctor
 children 6 to under 12 years  1 to 2 tsp (5 mL to 10 mL)

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • each tsp contains: sodium 5 mg 
  • store at 68o -77o F

INACTIVE INGRADIENTS

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

(609) 860-2600

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0693-1

DYE-FREE

Children's Allergy Relief 

Diphenhydramine HCl

12.5mg /5 mL Oral Solution 

Antihistamine

Cherry

Flavored Liquid

4-6 hours/Dose

Relief of:

Sneezing 

Runny Nose 

itchy, water eyes

itchy Throat

or Nose

Alcohol -Free

100% Money Back Guarantee

8 FL OZ (236 mL)

549-lbl.jpg549-lbl.jpg

549-box.jpg549-box.jpg

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0693-1Childrens Allergy Relief Dye Free236 mL in 1 BOTTLELIQUID2363
70000-0693-1Childrens Allergy Relief Dye Free1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0693CHILDRENS ALLERGY RELIEF DYE FREE (DIPHENHYDRAMINE HCL) LIQUID [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, 2 package rows20241023_198add5f-20b7-75b0-e063-6394a90a6bd4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0693-1ML - Milliliter70000-06931e6b8e0d-a9fb-4ec7-99d4-6256fe0f671212025-10-14

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
70000-069370000-0693-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT

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 Relief Dye FreeDIPHENHYDRAMINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER198add5f-20b7-75b0-e063-6394a90a6bd42024-10-21WarningsExact identifier
ndc (package): 70000-0693-1
ndc (product): 70000-0693
ndc11 (package): 70000069301
spl id: a44eced6-d593-4ddb-addb-43afab90a3d7
spl set id: 198add5f-20b7-75b0-e063-6394a90a6bd4

Reported adverse events (FAERS/openFDA)#

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