FDA.reportPublic FDA data

Painazol

Manufacturer
HelloLife, Inc. | Apotheca Company
Effective date
2023-10-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:23:47

Label at a glance#

ProductPainazol
Active ingredientACTAEA SPICATA ROOT, HORSE CHESTNUT, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CAUSTICUM, BLACK COHOSH, FORMIC ACID, HYPERICUM PERFORATUM, RHODODENDRON TOMENTOSUM LEAFY TWIG, LITHIUM CARBONATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, ANEMONE PRATENSIS, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SALICYLIC ACID, SEPIA OFFICINALIS JUICE, SULFUR, ZINC
Label structure9 sections

Dosage and administration

Dissolve under tongue. 30-50lb (13.6 kg-22.6kg): 1/2 tablet twice daily. 50lb+ (22.6kg): 1 tablet twice daily.

Storage and handling

Do not store next to electrical devices or appliances. Keep lid tightly closed & store in a cool, dry place.

Label contents#

Full prescribing information#

ACTIVE HPUS INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Actaea Spicata 10X, 20X, 30X, 200C, Aesculus Hippocastanum 10X, 20X, 30X, 200C, Arnica Montana 10X, 20X, 30X, 200C, Bellis Perennis 10X, 20X, 30X, 200C, Bryonia (Alba) 10X, 20X, 30X, 200C, Calcarea Carbonica 10X, 20X, 30X, 200C, Calcarea Fluorica 10X, 20X, 30X, 200C, Causticum 10X, 20X, 30X, 200C, Cimicifuga Racemosa 10X, 20X, 30X, 200C, Formicum Acidum 10X, 20X, 30X, 200C, Hypericum Perforatum 10X, 20X, 30X, 200C, Ledum Palustre 10X, 20X, 30X, 200C, Lithium Carbonicum 10X, 20X, 30X, 200C, Magnesia Phosphorica 10X, 20X, 30X, 200C, Phosphorus 10X, 20X, 30X, 200C, Phytolacca Decandra 10X, 20X, 30X, 200C, Pulsatilla (Pratensis) 10X, 20X, 30X, 200C, Rhododendron Chrysanthum 10X, 20X, 30X, 200C, Rhus Tox 10X, 20X, 30X, 200C, Ruta Graveolens 10X, 20X, 30X, 200C, Salicylicum Acidum 10X, 20X, 30X, 200C, Sepia 10X, 20X, 30X, 200C, Sulphur 10X, 20X, 30X, 200C, Zincum Metallicum 10X, 20X, 30X, 200C.

INDICATIONS FOR USE:

OTC - PURPOSE SECTION

For the temporary relief of symptoms such as:

• pain

• burning

• weakness

• sensitivity

• tingling

• numbness

Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

WARNINGS:

WARNINGS SECTION

Stop use and as a doctor if symptoms persist or worsen.

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

STORAGE & HANDLING:

STORAGE AND HANDLING SECTION

Do not store next to electrical devices or appliances.

Keep lid tightly closed & store in a cool, dry place.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Dissolve under tongue.

30-50lb (13.6 kg-22.6kg): 1/2 tablet twice daily.

50lb+ (22.6kg): 1 tablet twice daily.

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

For the temporary relief of symptoms such as:

• pain

• burning

• weakness

• sensitivity

• tingling

• numbness

Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Advantol 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by: HelloLife, Inc.

4635 40th St SE

Grand Rapids, MI 49512

Call us toll-free at:

1-800-875-0850 or visit us on

the web at www.hellolife.net

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49726-046-60
PAINAZOL
TABLETS
Natural Relief for
Respiratory Symptoms
Homeopathic (OTC) Medicine
60 Quick-dissolving Tablets

PainazolPainazol

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49726-04649726-046-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE2S7830E561IACT
COPOVIDONED9C330MD8BIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ACTAEA SPICATA ROOT3FU86L9OS0ACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
ARNICA MONTANAO80TY208ZWACTIB
BELLIS PERENNIS2HU33I03UYACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CAUSTICUMDD5FO1WKFUACTIB
BLACK COHOSHK73E24S6X9ACTIB
FORMIC ACID0YIW783RG1ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
LITHIUM CARBONATE2BMD2GNA4VACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
PHOSPHORUS27YLU75U4WACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ANEMONE PRATENSIS8E272251DIACTIB
RHODODENDRON AUREUM LEAFIV92NQJ73UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
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
28db6af1-100e-7470-e063-6394a90a6604d810ef0b-18eb-45c0-afd6-667c8d2588f62024-12-09WarningsExact identifier
spl set id: d810ef0b-18eb-45c0-afd6-667c8d2588f6

Reported adverse events (FAERS/openFDA)#

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