FDA.reportPublic FDA data

children allergy relief dye free cherry

Manufacturer
A-S Medication Solutions
Effective date
2023-11-01
Label type
Human OTC Drug Label
Version
6
Source
full-release
Hydrated at
2026-05-31 23:58:37

Label at a glance#

Productchildren allergy relief dye free cherry
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 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

find right dose on chart below mL=milliliter measure only with dosing cup provided do not use dosing cup with other products 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 5 mg dosing cup provided  store between 20 - 25 o C (68 o - 77 o F)

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

  • glaucoma
  • a breathing problem such as chronic bronchitis

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

  • 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

  • find right dose on chart below
  • mL=milliliter
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • 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 5 mg
  • dosing cup provided 
  • store between 20 - 25oC (68o- 77oF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-6163

NDC: 50090-6163-0 118 mL in a BOTTLE / 1 in a CARTON

CHILDREN ALLERGY RELIEF DYE FREE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN6
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD6
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY6
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY6
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY6

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6163-0children allergy relief dye free cherry118 mL in 1 BOTTLESOLUTION1186
50090-6163-0children allergy relief dye free cherry1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6163CHILDREN ALLERGY RELIEF DYE FREE CHERRY (DIPHENHYDRAMINE HCL) SOLUTION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20231102_5c6c1809-4c6f-4e8f-a5ae-9796e821d400.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6163-0ML - Milliliter50090-6163e546813a-3065-4e35-9a0c-376a8b587c0512022-11-07
70677-0144-1ML - Milliliter70677-0144d50457bd-c0d8-473f-a4c0-8170cab381bc12022-09-12
70677-0144-2ML - Milliliter70677-01440b0ec04e-40f2-4711-a1e3-bd1d2d8f358412022-10-06

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
50090-616350090-6163-0
70677-0144

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 SODIUM, UNSPECIFIED FORMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
glycerinPDC6A3C0OXIACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT

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
children allergy relief dye free cherryDIPHENHYDRAMINE HCLA-S Medication Solutions5c6c1809-4c6f-4e8f-a5ae-9796e821d4002023-11-01WarningsExact identifier
ndc (package): 50090-6163-0
ndc (product): 50090-6163
ndc11 (package): 50090616300
spl id: 93f6f565-a9ba-4bac-9227-b27a57b0204e
spl set id: 5c6c1809-4c6f-4e8f-a5ae-9796e821d400

Reported adverse events (FAERS/openFDA)#

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