FDA.reportPublic FDA data

ValuRx Dye Free Allergy Relief

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:41:48

Label at a glance#

ProductValuRx Dye Free Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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  temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 softgels children 6 to under 12 years 1 softgel children under 6 years  do not use

Label contents#

Full prescribing information#

Active ingredient (in each soft gel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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 
  • temporarily relieves these
  • symptoms due to the common cold: 
  • runny nose 
  • sneezing

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 you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis 
  • trouble urinating due to an enlarged
  • prostate gland 
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur 
  • avoid alcoholic drinks 
  • alcohol, sedatives and
  • tranquilizers may increase drowsiness 
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.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 times in 24 hours

    adults and children 12 years and over1 to 2 softgels
    children 6 to under 12 years1 softgel
    children under 6 years do not use

Other information

OTHER SAFETY INFORMATION

  • store between 20-25° C (68-77° F)
  • Avoid high humidity and excessive heat
  • protect from moisture and light

Inactive ingradient

INACTIVE INGREDIENT SECTION

gelatin, glycerin, isopropyl alcohol*, light mineral oil*, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981

SPL UNCLASSIFIED SECTION

Distributed by:

Shield Pharmaceuticals Corp.

Ronkonkoma, NY 11779

Principal display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dye Free Blister BoxDye Free Blister Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2

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
83059-0081-12025-11-02C16284748780-13b156c62-3450-fb37-e063-e6dba90a4e07ValuRx Dye Free Allergy Relief
83059-0081-12025-11-02C16284748780-13b156c62-3450-fb37-e063-e6dba90a4e07ValuRx Dye Free Allergy Relief
83059-0081-12025-07-29C16284748780-13b156c62-3450-fb37-e063-e6dba90a4e07ValuRx Dye Free Allergy Relief
83059-0081-12025-07-29C16284748780-13b156c62-3450-fb37-e063-e6dba90a4e07ValuRx Dye Free Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83059-0081-1ValuRx Dye Free Allergy Relief1 in 1 PACKAGECAPSULE, LIQUID FILLED12
83059-0081-1ValuRx Dye Free Allergy Relief12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-008183059-0081-1

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
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
SORBITAN6O92ICV9RUIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-02-17full-release2026-06-01 00:55:37

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
583a884c-cb9f-2794-e063-6394a90ab927ea7de21b-5dca-4cba-894c-3d56e2dc23e22026-08-04WarningsExact identifier
spl set id: ea7de21b-5dca-4cba-894c-3d56e2dc23e2

Reported adverse events (FAERS/openFDA)#

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