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#
Contacts and useful links#
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.
| Age | Dosage |
| Children 6 to 11 years | 5 mL to 10 mL |
| Children2 to 5 years | Do not use unless directed by a doctor |
| Children under 2 years | Do 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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 1 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 1 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 1 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 1 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0380513000552 | GTIN-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 | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-201-16 | Puregen Labs Allergy Relief | 473 mL in 1 BOTTLE | LIQUID | 473 | 1 |
Products#
Every source-derived product name is available through these pages.
- Puregen Labs Allergy Relief
- Diphenhydramine HCl
- FD&C RED NO. 40
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- SUCROSE
- ANHYDROUS CITRIC ACID
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80513-201 | 80513-201-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Puregen Labs Allergy Relief | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 4745d4f9-bbdf-a4a6-e063-6294a90a15b2 | 2025-12-31 | Warnings | 80513-201-16 80513-201 80513020116 4745d501-fbad-b33f-e063-6294a90a0753 4745d4f9-bbdf-a4a6-e063-6294a90a15b2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
