FDA.reportPublic FDA data

Real Relief

Manufacturer
Homeolab International (Canada) inc
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:12:08

Label at a glance#

ProductReal Relief
Active ingredientMATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, ERIODICTYON CALIFORNICUM LEAF, HISTAMINE DIHYDROCHLORIDE, IPECAC, LOBELIA INFLATA, SAMBUCUS NIGRA FLOWERING TOP, SOLIDAGO VIRGAUREA FLOWERING TOP
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:

Chamomila                                               8 [hp_X]

Coffea Cruda                                             8 [hp_X]

Eriodictyon californicum (Yerba santa)    8 [hp_X]

Histaminum                                              8 [hp_X]

Ipecacuanha (Ipecac)                                8  [hp_X]

Lobelia inflata (Indian tobacco)               8 [hp_X]

Sambucus nigra (European elder)           8 [hp_X]

Solidago virgaurea (Goldenrod)              8 [hp_X]

OTC - PURPOSE SECTION

Purpose

Homeopathic remedy helps relieve symptoms of asthma:

  • gasping for air
  • dry cough
  • difficulty breathing
  • irritability and nocturnal awakenings
  • wheezing
  • cough with mucus, cough with expectoration
  • restlessness and sleeplessness
  • excess mucus
  • irregular respiration

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 asthma:

  • gasping for air
  • difficulty breathing
  • wheezing
  • coughing
  • excess mucus

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 4 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
71971-6002-0Real Relief1 in 1 CARTONTABLET11
71971-6002-0Real Relief90 in 1 BOTTLETABLET901
71971-6002-5Real Relief30 in 1 BOTTLETABLET301
71971-6002-8Real Relief60 in 1 BOTTLETABLET601
71971-6002-8Real Relief1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71971-6002REAL RELIEF (CHAMOMILA, COFFEA CRUDA, ERIODICTYON CALIFORNICUM, HISTAMINUM, IPECACUANHA, LOBELIA INFLATA, SAMBUCUS NIGRA, SOLIDAGO VIRGAUREA) TABLET [HOMEOLAB INTERNATIONAL (CANADA) INC]1Current NDC, Legacy NDC, 5 package rows20200122_75cd0867-b3e8-4307-9c1a-8066b17f3471.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
71971-600271971-6002-0, 71971-6002-5, 71971-6002-8

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
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
ERIODICTYON CALIFORNICUM LEAF2Y7TIQ135HACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
IPECAC62I3C8233LACTIB
LOBELIA INFLATA9PP1T3TC5UACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Real ReliefDROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEALaboratoire Atlas Incfe18547a-0212-4cdf-accd-566ef122ff272025-10-08WarningsName fallback
brand name: Real Relief
Real ReliefDROSERA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUMLaboratoire Atlas Incdd9a33c7-2d6a-434f-acf4-0cdad467537d2025-10-08WarningsName fallback
brand name: Real Relief
Real ReliefDROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEALaboratoire Atlas Incfde58df6-a4b4-4d8b-b607-53d56a43bc6a2025-10-08WarningsName fallback
brand name: Real Relief
ChamomillaMATRICARIA CHAMOMILLABoiron851950ec-62cf-30ad-e053-2991aa0a19bd2024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron8519dcba-d2e1-ffb8-e053-2a91aa0a7ada2024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron851a3706-cc8c-b3f8-e053-2a91aa0ac0f52024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron8519c019-9944-7c11-e053-2a91aa0afddd2024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron85192110-5d56-59f7-e053-2a91aa0a48612024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron8519369a-b96f-4bf7-e053-2991aa0aee3a2024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron851978dd-d0dd-208c-e053-2a91aa0a30c52024-07-22Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron8519e65a-803a-2986-e053-2a91aa0aadfd2024-07-22Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron851950ec-62b1-30ad-e053-2991aa0a19bd2024-07-22Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron851a1844-b599-62c5-e053-2a91aa0a81742024-07-22Name fallback
generic name: MATRICARIA CHAMOMILLA
Real ReliefALLIUM CEPA, ARALIA RACEMOSA, ARSENICUM ALBUM, CUPRUM METALLICUM, EUPHRASIA OFFICINALIS, NUX VOMICA, SABADILLA, STICTA PULMONARIAGMP Laboratories of America, Inc.b79dbfd3-0048-06d8-e053-2a95a90adfbc2020-12-29WarningsName fallback
brand name: Real Relief
Real ReliefERIODICTYON CALIFORNICUM, HISTAMINUM, IPECACUANHA, LOBELIA INFLATA, SAMBUCUS NIGRA, SOLIDAGO VIRGAUREAGMP Laboratories of America, Inc.b79f7319-1ecc-77f5-e053-2a95a90a5a812020-12-29WarningsName fallback
brand name: Real Relief
Real ReliefCHAMOMILA, COFFEA CRUDA, ERIODICTYON CALIFORNICUM, HISTAMINUM, IPECACUANHA, LOBELIA INFLATA, SAMBUCUS NIGRA, SOLIDAGO VIRGAUREAGMP Laboratories of America, Inc.b7a030d9-0644-4778-e053-2995a90a57c72020-12-29WarningsName fallback
brand name: Real Relief
Real ReliefAPIS MELLIFICA, ARNICA MONTANA, BENZOICUM ACIDUM, CAUSTICUM, COLCHICUM AUTUMNALE, NATRUM CARBONICUMGMP Laboratories of America, Inc.b7a1ce34-a996-22cf-e053-2a95a90afa452020-12-29WarningsName fallback
brand name: Real Relief
Real ReliefARNICA MONTANA, BRYONIA, CAUSTICUM, CINCHONA OFFICINALIS, DULCAMARA, HYDRASTIS CANADENSIS, KALI BROMATUM, SULPHURGMP Laboratories of America, Inc.b7a1fb57-3f47-7cf2-e053-2a95a90a312c2020-12-29WarningsName fallback
brand name: Real Relief
Real ReliefDROSERA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUMHomeolab International (Canada) inccec096cd-5f77-4ca8-bf63-fc0c95127c152019-12-10WarningsName fallback
brand name: Real Relief
Real ReliefDROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEAHomeolab International (Canada) incfc6a509a-f4c0-47e7-8693-906ba6e039232019-12-10WarningsName fallback
brand name: Real Relief

Reported adverse events (FAERS/openFDA)#

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