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 02:14:04

Label at a glance#

ProductReal Relief
Active ingredientARNICA MONTANA, BRYONIA ALBA ROOT, CAUSTICUM, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA TOP, GOLDENSEAL, POTASSIUM BROMIDE, SULFUR
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:

Arnica montana (Leopard's bane)            8[hp-X]

Bryonia (White bryony)                          8 [hp-X]

Causticum (Hahnmann's causticum)        8 [hp-X]

Cinchona officinalis (Peruvian bark)        8 [hp-X]

Dulcamara (Bittersweet)                          8 [hp-X]

Hydrastis canadensis (Golden seal)          8 [hp-X]

Kali bromatum (Potassium bromide)       8 [hp-X]

Sulphur (Sublimed sulfur)                       8 [hp-X]

OTC - PURPOSE SECTION

Purpose

Homeopathic remedy helps relieve symptoms of tinnitus:

  • Rigging and buzzing in the ears
  • Ear pain & pressure
  • Headache

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 medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated

  • with tinnitus
  • Rigging and buzzing in the ears
  • Ear pain & pressure
  • Headache

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

Label1Label1

Label2Label2

Label3Label3

Label4Label4

Label5Label5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65808-326-01Real Relief1 in 1 CARTONTABLET12
65808-326-01Real Relief90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65808-326REAL RELIEF (ARNICA MONTANA, BRYONIA, CAUSTICUM, CINCHONA OFFICINALIS, DULCAMARA, HYDRASTIS CANADENSIS, KALI BROMATUM, SULPHUR) TABLET [GMP LABORATORIES OF AMERICA, INC.]2Current NDC, Legacy NDC, 2 package rows20201230_b7a1fb57-3f47-7cf2-e053-2a95a90a312c.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
65808-32665808-326-01

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
ARNICA MONTANAO80TY208ZWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CAUSTICUMDD5FO1WKFUACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
SULFUR70FD1KFU70ACTIB

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 ReliefARNICA MONTANA, BRYONIA, CAUSTICUM, CINCHONA OFFICINALIS, DULCAMARA, HYDRASTIS CANADENSIS, KALI BROMATUM, SULPHURGMP Laboratories of America, Inc.b7a1fb57-3f47-7cf2-e053-2a95a90a312c2020-12-29WarningsExact identifier
ndc (package): 65808-326-01
ndc (product): 65808-326
ndc11 (package): 65808032601
spl id: b7a21773-caf1-2960-e053-2995a90ada31
spl set id: b7a1fb57-3f47-7cf2-e053-2a95a90a312c

Reported adverse events (FAERS/openFDA)#

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