Regen

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-07-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:27:29

Label at a glance#

ProductRegen HP
Active ingredientCINNAMON, ECHINACEA ANGUSTIFOLIA WHOLE, GOLDENSEAL, ARCTIUM LAPPA ROOT, TRIFOLIUM PRATENSE FLOWER
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 6.67% of Cinnamomum 12X, 30X, 200X, Echinacea (Angustifolia) 12X, 30X, 200X, Hydrastis Canadensis 12X, 30X, 200X, Lappa Major 12X, 30X, 200X, Trifolium Pratense 12X, 30X, 200X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve sore throat, extreme fatigue, glandular swelling and mucous discharge.**

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

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

KEEP OUT OF REACH OF CHILDREN:

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve sore throat, extreme fatigue, glandular swelling and mucous discharge.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

REGEN HP

2 fl. oz. (60 ml)

Regen HPRegen HP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0529-12024-07-03C16284748780-1d6a99b39-6d55-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0529-12022-01-28C16284748780-1d6a99b39-6d55-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0529-1RegenHP60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0529REGEN HP (CINNAMOMUM, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LAPPA MAJOR, TRIFOLIUM PRATENSE) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240704_6c796f64-29a0-4e87-871a-88fbeb7a1d61.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-052944911-0529-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
Regen HPCINNAMOMUM, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LAPPA MAJOR, TRIFOLIUM PRATENSEEnergique, Inc.6c796f64-29a0-4e87-871a-88fbeb7a1d612024-07-03WarningsExact identifier
ndc (package): 44911-0529-1
ndc (product): 44911-0529
ndc11 (package): 44911052901
spl id: 85274eb1-fa39-4368-8941-bce499fa787a
spl set id: 6c796f64-29a0-4e87-871a-88fbeb7a1d61

Reported adverse events (FAERS/openFDA)#

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