FDA.reportPublic FDA data

Real Relief

Manufacturer
GMP Laboratories of America, Inc.
Effective date
2020-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:14:03

Label at a glance#

ProductReal Relief
Active ingredientONION, ARALIA RACEMOSA ROOT, ARSENIC TRIOXIDE, COPPER, EUPHRASIA STRICTA, STRYCHNOS NUX-VOMICA SEED, SCHOENOCAULON OFFICINALE SEED, LOBARIA PULMONARIA
Label structure9 sections

Storage and handling

Other information Store at room temperature. Do not use if seal is broken or missing.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients HPUS:

Allium cepa (Onion)                              8 [hp-X]

Aralia racemosa (Spikenard)                  8 [hp-X]

Arsenicum album (Arsenous trioxyde)   8 [hp-X]

Cuprum metallicum (Metallic copper)   8 [hp-X]

Euphrasia officinalis (Eyebright)           8 [hp-X]

Nux vomica (Poison nut)                        8 [hp-X]

Sabadilla (Sabadilla)                              8 [hp-X]

Sticta pulmonaria (Lungwort)               8 [hp-X]

OTC - PURPOSE SECTION

Purpose

Homeopathic remedy helps relieve symptoms of all types of allergies:

  • itchy, watery eyes
  • red burning eyes and sneezing
  • nasal congestion, coryza
  • burning and swelling of the eye lids
  • sneezing, runny nose, hay fever
  • hay fever, sneezing, runny nose
  • dry cough, hay fever
  • itchy eyes, nasal congestion

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated

INDICATIONS & USAGE SECTION

Uses

This homeopathic remedy to relieve from symptoms of all allergies

  • Nasal congestion
  • Sneezing
  • Runny nose
  • Itchy, watery eyes

WARNINGS SECTION

Warnings

Stop use and ask a doctor if symptoms worsen or last for more than 7 days.

If you are pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, contact a medical professional or poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 times daily and reduce intake with improvement or as directed by a health professional

Age…………………………………………………………........ Dose

Adults and Children 12 years of age and older………...... 2 tablets

Children 2 to 11 years of age…...……………………............ 1 tablet

Children under 2 years of age……………………................. Ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature.
  • Do not use if seal is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Lactose, Magnesium Stearate.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

image descriptionimage description

image descriptionimage description

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65808-318-01Real Relief1 in 1 CARTONTABLET12
65808-318-01Real Relief90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65808-318REAL RELIEF (ALLIUM CEPA, ARALIA RACEMOSA, ARSENICUM ALBUM, CUPRUM METALLICUM, EUPHRASIA OFFICINALIS, NUX VOMICA, SABADILLA, STICTA PULMONARIA) TABLET [GMP LABORATORIES OF AMERICA, INC.]2Current NDC, Legacy NDC, 2 package rows20201230_b79dbfd3-0048-06d8-e053-2a95a90adfbc.zip

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
65808-31865808-318-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
ONION492225Q21HACTIB
ARALIA RACEMOSA ROOTT90W4582DUACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
COPPER789U1901C5ACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB

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
Real ReliefALLIUM CEPA, ARALIA RACEMOSA, ARSENICUM ALBUM, CUPRUM METALLICUM, EUPHRASIA OFFICINALIS, NUX VOMICA, SABADILLA, STICTA PULMONARIAGMP Laboratories of America, Inc.b79dbfd3-0048-06d8-e053-2a95a90adfbc2020-12-29WarningsExact identifier
ndc (package): 65808-318-01
ndc (product): 65808-318
ndc11 (package): 65808031801
spl id: b79d513b-e854-799c-e053-2995a90aa022
spl set id: b79dbfd3-0048-06d8-e053-2a95a90adfbc

Reported adverse events (FAERS/openFDA)#

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