FDA.reportPublic FDA data

Mineffect cold remedy

Manufacturer
Kadesh Incoporation Co,Ltd
Effective date
2023-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:22:58

Label at a glance#

ProductMineffect cold remedy
Active ingredientCALCIUM FLUORIDE, IRON, FERROSOFERRIC PHOSPHATE, PHOSPHORUS, SILICON DIOXIDE, SULFUR, ZINC
Label structure10 sections

Indications and uses

• Reduces the duration and severity of common cold symptoms • Temporarily relieves symptoms of common cold such as Sneezing, Cough, Sore Throat, and Runny Nose.

Storage and handling

*Store at room temperature.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcarea Flourica 6X HPUS
Ferrum Metallicum 7X HPUS
Ferrum Phosphoricum 7X HPUS
Phosphorus 6X HPUS
Silicea 4X HPUS
Sulphur 4X HPUS
Zincum Metallicum 8X HPUS

Purpose

OTC - PURPOSE SECTION

Throat Pain
Cough, Sneezing
Cough, Sore Chest
Sore Throat
Cough, Sore Throat
Sore Throat
Muscus, Runny Nose

The letters HPUS indicate that this ingredients is officially included in the Homeopathic pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

• Reduces the duration and severity of common cold symptoms
• Temporarily relieves symptoms of common cold such as Sneezing, Cough, Sore Throat, and Runny Nose.

Warning

WARNINGS SECTION

Do not Use*If the tamper resistant label is broken.

Consult a physician if:
• Symptoms persist for more than 7 days or worsen.
• Inflammation, fever, or infection develops.

When using this product*To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children

Direction

DOSAGE & ADMINISTRATION SECTION

Take 30ml every 6 hours while the cold symptoms persist.

Other Information

STORAGE AND HANDLING SECTION

*Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Distilled Water, Alumina, Alumina Silicata, Cerium Oxalicum, Kali Silicatum, Magnesia Muriatica, Magnesia Sulphurica, Natrum Nitricum

Questions or Comments?

OTC - QUESTIONS SECTION

1-844-KADESH1

Mon-Fri 9am - 6pm (PST)
www.puriton.us
201, Eonju-ro, Gangnam-gu, Seoul
South Korea 06274

SPL UNCLASSIFIED SECTION

homeopathic

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mineffect-009mineffect-009

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81488-009-01Mineffect cold remedy30 mL in 1 BOTTLELIQUID302
81488-009-01Mineffect cold remedy1 in 1 BOXLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81488-009MINEFFECT COLD REMEDY (CALCAREA FLOURICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, SILICEA, SULPHUR, ZINCUM METALLICUM) LIQUID [KADESH INCOPORATION CO,LTD]2Current NDC, Legacy NDC, 2 package rows20231101_14d2a1fe-a1f1-4e85-96c0-d8b90260336c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81488-00981488-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALUMINUM OXIDELMI26O6933IACT
KAOLIN24H4NWX5COIACT
CEROUS OXALATE NONAHYDRATE0UV74P3R0JIACT
POTASSIUM SILICATEJ86L1GUL6KIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
SODIUM NITRATE8M4L3H2ZVZIACT
CALCIUM FLUORIDEO3B55K4YKIACTIB
IRONE1UOL152H7ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
PHOSPHORUS27YLU75U4WACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SULFUR70FD1KFU70ACTIB
ZINCJ41CSQ7QDSACTIB

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
Mineffect cold remedyCALCAREA FLOURICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, SILICEA, SULPHUR, ZINCUM METALLICUMKadesh Incoporation Co,Ltd14d2a1fe-a1f1-4e85-96c0-d8b90260336c2023-10-31WarningsExact identifier
ndc (package): 81488-009-01
ndc (product): 81488-009
ndc11 (package): 81488000901
spl id: 0906ab71-cd97-8a1f-e063-6394a90ab610
spl set id: 14d2a1fe-a1f1-4e85-96c0-d8b90260336c

Reported adverse events (FAERS/openFDA)#

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