FDA.reportPublic FDA data

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Manufacturer
PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO
Effective date
2013-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:33

Label at a glance#

ProductCombination Product
Active ingredientACONITUM NAPELLUS, BAPTISIA TINCTORIA ROOT, BRYONIA DIOICA ROOT, CAMPHOR (NATURAL), CAUSTICUM, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERRIC PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, SCHOENOCAULON OFFICINALE SEED
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Enter section text here

Active ingredients
Aconitum napellus 4X, Baptisia tinctoria 4X, Bryonia 4X, Camphora 3X, Causticum 6X, Eucalyptus globulus 3X, Eupatorium perfoliatum 3X, Ferrum phosphoricum 8X, Gelsemium sempervirens 6X, Sabadilla 6X, 1 g each in 10 g.

OTC - PURPOSE SECTION

Enter section text here

Purpose
Relieves symptoms associated with colds and flu

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of minor symptoms associated with colds and flu:

    * Sneezing
    * Running nose
    * Coughing
    * Minor sore throat pain
    * Fever

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use

    * in children younger than 2 years

OTC - STOP USE SECTION

Stop use and ask a doctor if

    * symptoms persist for more than 7 days (5 days for children)
    * fever persists for more than 3 days
    * symptoms worsen or if new symptoms occur
    * redness or swelling is present, because these could be signs of a serious condition
    * sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions
Adults: 10-15 drops; children (6-12 years of age): 5-8 drops;
children (2-6 years of age): 2-5 drops, every 15 minutes to 2 hours in a little water or undiluted or as recommended.
Not recommended for children under 2 years of age except under the advice of a health care professional.

OTHER SAFETY INFORMATION

Other information

    * Tamper resistant: Do not use if safety ring at base of cap is broken.
    * Retain outer carton for full product instructions.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Ethanol, purified water.

OTC - QUESTIONS SECTION

Questions?

Call 1-800-361-7872 or email questions@reckeweg.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of carton labelNDC# 53346-1306-5

Dr. Reckeweg R6 Gripfektan

Homeopathic preparation for the temporary relief of minor symptoms associated with colds and flu:

    * Sneezing
    * Running nose
    * Coughing
    * Minor sore throat pain
    * Fever


Manufactured by:
Dr. Reckeweg Co. GmbH
D-64625 Bensheim
Germany

1.68 fl oz
(50 ml)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53346-1306-52019-11-27C16284748780-19855d018-e8a6-cd31-e053-dbdaa90ab51aDR. RECKEWEG R6 Gripfektan

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53346-1306-5Combination Product50 mL in 1 BOTTLELIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53346-1306COMBINATION PRODUCT (ACONITUM NAPELLUS 4X, BAPTISIA TINCTORIA 4X, BRYONIA 4X, CAMPHORA 3X, CAUSTICUM 6X, EUCALYPTUS GLOBULUS 3X, EUPATORIUM PERFOLIATUM 3X, FERRUM PHOSPHORICUM 8X, GELSEMIUM SEMPERVIRENS 6X, SABADILLA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]21 package rows20130506_a1ee5fce-c222-4e97-ba6c-e61f95cc057a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD2
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WU2
BRYONIA DIOICA ROOTACTIVE INGREDIENT53UB5FH7CX2
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9412
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU2
EUCALYPTUS GLOBULUS LEAFACTIVE INGREDIENTS546YLW6E62
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6E2
FERRIC PHOSPHATEACTIVE INGREDIENTN6BAA189V12
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q2
SCHOENOCAULON OFFICINALE SEEDACTIVE INGREDIENT6NAF1689IO2
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD2
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WU2
BRYONIA CRETICA SUBSP. DIOICA ROOTACTIVE MOIETY53UB5FH7CX2
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9412
CAUSTICUMACTIVE MOIETYDD5FO1WKFU2
EUCALYPTUS GLOBULUS LEAFACTIVE MOIETYS546YLW6E62
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6E2
FERRIC CATIONACTIVE MOIETY91O4LML6112
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q2
SCHOENOCAULON OFFICINALE SEEDACTIVE MOIETY6NAF1689IO2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53346-130653346-1306-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BRYONIA DIOICA ROOT53UB5FH7CXACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
CAUSTICUMDD5FO1WKFUACTIB
EUCALYPTUS GLOBULUS LEAFS546YLW6E6ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
FERRIC PHOSPHATEN6BAA189V1ACTIM
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
bebd30cb-67cb-4bd4-89cd-147d1d7b4ec0a1ee5fce-c222-4e97-ba6c-e61f95cc057a2013-05-06WarningsExact identifier
spl id: bebd30cb-67cb-4bd4-89cd-147d1d7b4ec0
spl set id: a1ee5fce-c222-4e97-ba6c-e61f95cc057a

Reported adverse events (FAERS/openFDA)#

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