MedPath

Schuessler Tissue Salts Comb 12 General Tonic

Approved
Approval ID

9083a01b-2fbe-4e04-9eec-bf4f65950ec7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Martin & Pleasance Pty Ltd

DUNS: 752869859

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Calcarea Fluorica,Calcarea Phosphorica,Calcarea Sulphurica,Ferrum Phosphoricum,Kali Phosphoricum,Kali Muriaticum,Kali Sulphuricum,Magnesia Phosphorica,Natrum Muriaticum,Natrum Phosphoricum,Natrum Sulphuricum,Silicea

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84999-029
Product Classification
G
Generic Name
Calcarea Fluorica,Calcarea Phosphorica,Calcarea Sulphurica,Ferrum Phosphoricum,Kali Phosphoricum,Kali Muriaticum,Kali Sulphuricum,Magnesia Phosphorica,Natrum Muriaticum,Natrum Phosphoricum,Natrum Sulphuricum,Silicea
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (15)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CALCIUM FLUORIDEActive
Quantity: 6 [hp_X] in 1 1
Code: O3B55K4YKI
Classification: ACTIM
TRIBASIC CALCIUM PHOSPHATEActive
Quantity: 6 [hp_X] in 1 1
Code: 91D9GV0Z28
Classification: ACTIM
CALCIUM SULFATE DIHYDRATEActive
Quantity: 6 [hp_X] in 1 1
Code: 4846Q921YM
Classification: ACTIB
FERROUS PHOSPHATEActive
Quantity: 6 [hp_X] in 1 1
Code: D07L04MRWI
Classification: ACTIB
DIBASIC POTASSIUM PHOSPHATEActive
Quantity: 6 [hp_X] in 1 1
Code: CI71S98N1Z
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 6 [hp_X] in 1 1
Code: 660YQ98I10
Classification: ACTIM
POTASSIUM SULFATEActive
Quantity: 6 [hp_X] in 1 1
Code: 1K573LC5TV
Classification: ACTIB
MAGNESIUM PHOSPHATE, DIBASICActive
Quantity: 6 [hp_X] in 1 1
Code: A1Y870209Z
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6 [hp_X] in 1 1
Code: 451W47IQ8X
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSActive
Quantity: 6 [hp_X] in 1 1
Code: 22ADO53M6F
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 6 [hp_X] in 1 1
Code: 36KCS0R750
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 6 [hp_X] in 1 1
Code: ETJ7Z6XBU4
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/14/2025

Product label

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/14/2025

Uses

Temporarily relieves symptoms associated with

  • General debility
  • Fatigue
  • Exhaustion
  • Tension

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/14/2025

Active Ingredients Purpose

Calcarea Fluorica 6X HPUS ........................................................general debility
Calcarea Phosphorica 6X HPUS..................................................general debility
Calcarea Sulphurica 6X HPUS ................................................................ fatigue
Ferrum Phosphoricum 6X HPUS. ..................general debility, fatigue, exhaustion
Kali Muriaticum 6X HPUS..................................................... fatigue, exhaustion
Kali Phosphoricum 6X HPUS ..................................................................tension
Kali Sulphuricum 6X HPUS................................................... fatigue, exhaustion
Magnesia Phosphorica 6X HPUS ............................. fatigue, exhaustion, tension
Natrum Muriaticum 6X HPUS ................................................................. fatigue
Natrum Phosphoricum 6X HPUS............................................................. fatigue
Natrum Sulphuricum 6X HPUS ............................................................... fatigue
Silicea 6X HPUS..................................................................................... fatigue

" HPUS" is the Homeopathic Pharmacopoeia of the United States

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/14/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 8/14/2025

Warnings

Ask a doctor before use if you have:

  • Symptoms persist for more than 7 days or worsen
  • New symptoms occur
  • Redness, swelling, or inflammation is present
  • Pain gets worse or lasts more than 7 days.

If pregnant or breastfeeding, ask a health professional before use.Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/14/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/14/2025

Directions

  • Use as directed
  • Take 30 minutes away from food.

Adults:

  • Acute dose: Chew 1 tablet every 30 minutes until symptoms subside, up to 6 times per day.
  • Maintenance dose: Chew 1 tablet, 4 times daily.

Children 6 years and older:

  • Acute dose: Crush ½ tablet, dissolve in water, and take every 30 minutes until symptoms subside, up to 6 times per day.
  • Maintenance dose: Crush ½ tablet, dissolve in water, 4 times per day.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/14/2025

Questions? www.schuesslertissuesalts.co or + 1-888-464-6775

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/14/2025

Inactive Ingredients

Calcium hydrogen phosphate, Lactose, Magnesium stearate.

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Schuessler Tissue Salts Comb 12 General Tonic - FDA Drug Approval Details