Puregen Labs Allergy Relief

Manufacturer
Advanced Rx LLC
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:30:15

Label at a glance#

ProductPuregen Labs Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

Uses

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

WARNINGS SECTION

Warnings

Do not use

  • with any other product conatining diphenhydramine, including one used on the skin
  • to make a child sleepy

Ask a doctor before use if you have

  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives, and tranquilizers may increase drowsiness

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • take every 4 to 6 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • use dosing cup provided.
AgeDosage
Children 6 to 11 years5 mL to 10 mL
Children2 to 5 yearsDo not use unless directed by a doctor
Children under 2 yearsDo not use

INACTIVE INGREDIENT SECTION

Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.

OTC - QUESTIONS SECTION

Questions or comments? 1-800-630-8895

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PuregenAllergyPuregenAllergy

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1

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
BarcodeEAN-130380513000552GTIN-13: 0380513000552
EAN-13: 0380513000552
GTIN-12: 380513000552
UPC-A: 380513000552
GTIN storage (14 digits): 00380513000552
PUregenAllergy.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-201-16Puregen Labs Allergy Relief473 mL in 1 BOTTLELIQUID4731

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
80513-20180513-201-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
Puregen Labs Allergy ReliefDIPHENHYDRAMINE HCLAdvanced Rx LLC4745d4f9-bbdf-a4a6-e063-6294a90a15b22025-12-31WarningsExact identifier
ndc (package): 80513-201-16
ndc (product): 80513-201
ndc11 (package): 80513020116
spl id: 4745d501-fbad-b33f-e063-6294a90a0753
spl set id: 4745d4f9-bbdf-a4a6-e063-6294a90a15b2

Reported adverse events (FAERS/openFDA)#

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