FDA.reportPublic FDA data

DYE-FREE ALLERGY

Manufacturer
PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2020-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:49

Label at a glance#

ProductDYE-FREE ALLERGY
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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 do not take more than 6 doses 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 this product in children under 6 years of age

Storage and handling

store at room temperature 15°-30°C (59°-86°F) in a dry place protect from heat, humidity, and light

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
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

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 you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking 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
  • do not take more than 6 doses 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 this product in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F) in a dry place
  • protect from heat, humidity, and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-800-833-6278

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DYE-FREE ALLERGY 24 SOFTGELS

Diphenhydramine HCl 25mg

NDC 51013-144-04

*Compare to the active ingredient in Benadryl® Dye-Free Allergy Liqui-Gels®

Carton LabelCarton Label

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
51013-144-042025-01-30C16284748780-12cef2736-6913-d83d-e063-dadaa90ab31fDYE-FREE ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-144-04DYE-FREE ALLERGY12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
51013-144-04DYE-FREE ALLERGY2 in 1 CARTONCAPSULE, LIQUID FILLED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-144DYE-FREE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 2 package rows20200104_ed3be505-045d-4ebd-b4ea-7f04ceadfe6a.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51013-14451013-144-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
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
be59b33e-95a6-4d13-b366-02130e4e5c5bed3be505-045d-4ebd-b4ea-7f04ceadfe6a2020-01-03WarningsExact identifier
spl id: be59b33e-95a6-4d13-b366-02130e4e5c5b
spl set id: ed3be505-045d-4ebd-b4ea-7f04ceadfe6a

Reported adverse events (FAERS/openFDA)#

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