FDA.reportPublic FDA data

R16

Manufacturer
Apex Energetics Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:31

Label at a glance#

ProductR16 BRONCHI
Active ingredientADENOSINE TRIPHOSPHATE, COPPER, STRYCHNOS IGNATII SEED, PLATINUM, SILICON DIOXIDE, CALCIUM IODIDE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure7 sections

Dosage and administration

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Adenosine Triphosphate

5X

Calcarea Iodata

2LM

Cuprum Metallicum

2LM

Ignatia Amara

2LM

Platinum Metallicum

2LM

Silicea

1LM

Thuja Occidentalis

2X 3X 6X 8X 12X 1C 2C 3C 5C 6C 7C 1LM

INDICATIONS & USAGE SECTION

Uses:

OTC - PURPOSE SECTION

For temporary relief of minor:

respiratory congestion*

cough*

mucus*

post nasal catarrh*

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

Warnings:

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTHER SAFETY INFORMATION

Do not use if clear seal over the cap is broken or missing.

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if respiratory congestion, cough, mucus, post nasal catarrh, or other symptoms do not improve within 7 days or are accompanied by fever.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol (20% by volume), distilled water

OTC - QUESTIONS SECTION

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® R16

REGENRX®

BRONCHI

Homeopathic Formula

Respiratory Congestion*

Cough* Mucus*

1 fl oz (30 mL)

Alcohol 20% by Volume

R16 Bronchi 20201023 label.jpgR16 Bronchi 20201023 label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1816-1R16BRONCHI30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1816R16 BRONCHI (ADENOSINE TRIPHOSPHATE, CALCAREA IODATA, CUPRUM METALLICUM, IGNATIA AMARA, PLATINUM METALLICUM, SILICEA, THUJA OCCIDENTALIS) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_c0f759b1-d7f8-12b3-e053-2a95a90a8768.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-181663479-1816-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADENOSINE TRIPHOSPHATE8L70Q75FXEACTIB
COPPER789U1901C5ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
PLATINUM49DFR088MYACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
CALCIUM IODIDE8EKI9QEE2HACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB

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
R16 BRONCHIADENOSINE TRIPHOSPHATE, CALCAREA IODATA, CUPRUM METALLICUM, IGNATIA AMARA, PLATINUM METALLICUM, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.c0f759b1-d7f8-12b3-e053-2a95a90a87682024-01-08WarningsExact identifier
ndc (package): 63479-1816-1
ndc (product): 63479-1816
ndc11 (package): 63479181601
spl id: 0e7729de-1050-e578-e063-6394a90a7de6
spl set id: c0f759b1-d7f8-12b3-e053-2a95a90a8768

Reported adverse events (FAERS/openFDA)#

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