Dye Free Allergy Relief

Manufacturer
Topco Associates, LLC
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:41:43

Label at a glance#

ProductDye Free Allergy Relief
Active ingredientDIPHENHYDRAMINE HCL
Label structure11 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 & children 12 yrs & over 1 to 2 Softgels children 6 to under 12 yrs 1 Softgel children under 6 yrs do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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

OTC - WHEN USING SECTION

When using this product

  • 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 & children 12 yrs & over1 to 2 Softgels
children 6 to under 12 yrs1 Softgel
children under 6 yrsdo 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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981 (toll-free)

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Distributed by:
Topco Associates LLC
Itasca, IL 60143

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare health

Dye-Free
Allergy Relief

Diphenhydramine HCl 25 mg


Relieves

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

Diphenhydramine HCl 25 mg
No artificial flavors
No synthetic colors
Gluten free*
Non-GMO

Carton

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/49123aTopCo-Dye-Free Box.jpg

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
76162-914-24Dye Free Allergy Relief2 in 1 CARTONCAPSULE, LIQUID FILLED24
76162-914-24Dye Free Allergy Relief12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

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
76162-91476162-914-24

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-06-09full-release2026-06-01 01:02:39

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
Dye Free Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLC6ddf6b16-0ff3-4014-9f73-33e854397fe52025-10-31WarningsExact identifier
ndc (package): 76162-914-24
ndc (product): 76162-914
ndc11 (package): 76162091424
spl id: 4279e83d-bb78-a1f8-e063-6394a90a0238
spl set id: 6ddf6b16-0ff3-4014-9f73-33e854397fe5

Reported adverse events (FAERS/openFDA)#

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