FDA.reportPublic FDA data

Triple Complex Digestion Tonic

Manufacturer
Native Remedies, LLC | Vitality Works, Inc
Effective date
2013-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:26

Label at a glance#

ProductTriple Complex Digestion Tonic
Active ingredientTRIBASIC CALCIUM PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Label structure12 sections

Storage and handling

Tamper resistant for your protection. Use only if safety seal is intact

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Reduce digestive upset and improves digestion

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Each dose contains equal parts of: Calc phos 8X HPUS, Kali phos 6X HPUS, Nat phos 6C HPUS

INDICATIONS & USAGE SECTION

Uses: Homeopathic remedy for relieving symptoms of digestive discomfort

WARNINGS SECTION

Warnings: If symptoms persist or worsen, consult a healthcare professional

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions: For all ages: Acute: Take 0.25 mL to 0.50 mL every hour for up 10 servings or until symptoms subside. Chronic: Take 0.25 mL to 0.50 mL 3 times daily

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water, USP Grain Alcohol (20% by volume), Lactose

INFORMATION FOR PATIENTS SECTION

The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.con

Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd,
Suite 160
Boca Raton, FL 33487
Phone: +1.877.289.1235
International :+1.561.999.8857

Contains no animal products, gluten, artificial flavors, preservatives or colorants

STORAGE AND HANDLING SECTION

Tamper resistant for your protection. Use only if safety seal is intact

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130818837010099GTIN-13: 0818837010099
EAN-13: 0818837010099
GTIN-12: 818837010099
UPC-A: 818837010099
GTIN storage (14 digits): 00818837010099		DIG202.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-043-602020-01-31C16284748780-19d75b9d0-886c-f424-e053-dadaa90a57ceTriple Complex Digestion Tonic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-043-60Triple Complex Digestion Tonic59 mL in 1 BOTTLE, GLASSTINCTURE591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-043TRIPLE COMPLEX DIGESTION TONIC (CALC PHOS, KALI PHOS, NAT PHOS) TINCTURE [NATIVE REMEDIES, LLC]1Legacy NDC, 1 package rows20130403_72830e2a-11fb-4cd1-9a20-72ae5b9059da.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z1
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4B1
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z281
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
68703-04368703-043-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
LACTOSEJ2B2A4N98GIACT

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 2 · 95 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, DELAYED RELEASE / ORAL160 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSUPPOSITORY / VAGINALNAExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / RECTAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAMUSCULAR203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GFILM, EXTENDED RELEASE / TRANSDERMAL675 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / VAGINAL430 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, CHEWABLE / ORAL1412 mgExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii candidate
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 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
8f8a347b-b8d4-4df1-9d71-bb97da8d924a72830e2a-11fb-4cd1-9a20-72ae5b9059da2013-04-03WarningsExact identifier
spl id: 8f8a347b-b8d4-4df1-9d71-bb97da8d924a
spl set id: 72830e2a-11fb-4cd1-9a20-72ae5b9059da

Reported adverse events (FAERS/openFDA)#

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