Indications and uses
Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
Constipation
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-01-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:31:40
Label at a glance#
ProductConstipation
Active ingredientZINC, ECHINACEA, UNSPECIFIED, COLLINSONIA CANADENSIS ROOT, PHYTOLACCA AMERICANA ROOT, TARAXACUM OFFICINALE, PICEA MARIANA RESIN, HORSE CHESTNUT, ALOE, ALUMINUM OXIDE, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, CHELIDONIUM MAJUS, GOLDENSEAL, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CHLORIDE, DAPHNE MEZEREUM BARK, STRYCHNOS NUX-VOMICA SEED, PODOPHYLLUM, KRAMERIA LAPPACEA ROOT, SANICULA EUROPAEA LEAF, SELENIUM, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, TOBACCO LEAF, VERATRUM ALBUM ROOT, GRAPHITE, IRIS VERSICOLOR ROOT
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS AND USAGE SECTION
Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
DOSAGE & ADMINISTRATION SECTION
Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Iris versicolor 6x, Phytolacca decandra 6x, Taraxacum officinale 6x, Abies nigra 15x, Aesculus hippocastanum 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo vegetabilis 15x, Chelidonium majus 15x, Collinsonia canadensis 15x, Graphites 15x, Hydrastis canadensis 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Magnesia muriatica 15x, Mezereum 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium metallicum 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum album 15x, Zincum metallicum 15x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
INACTIVE INGREDIENT SECTION
Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
QUESTIONS SECTION
newtonlabs.net – Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
WARNINGS SECTION
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
PACKAGE LABEL
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1723-1 | Constipation | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-1723 | CONSTIPATION (ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUM) PELLET [NEWTON LABORATORIES, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250130_9d63b107-cd47-d9a5-e053-2a95a90a4493.zip |
Products#
Every source-derived product name is available through these pages.
- Constipation
- Echinacea, Iris versicolor, Phytolacca decandra, Taraxacum officinale, Abies nigra, Aesculus hippocastanum, Aloe, Alumina, Bryonia, Carbo vegetabilis, Chelidonium majus, Collinsonia canadensis, Graphite, Hydrastis canadensis 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Magnesia muriatica 15x, Mezereum, Nux vomica, Podophyllum peltatum, Rhamnus purshiana, Sanicula, Selenium metallicum, Sepia, Silicea, Tabacum, Veratrum album, Zincum metallicum
- ZINC
- ECHINACEA, UNSPECIFIED
- COLLINSONIA CANADENSIS ROOT
- PHYTOLACCA AMERICANA ROOT
- TARAXACUM OFFICINALE
- PICEA MARIANA RESIN
- HORSE CHESTNUT
- ALOE
- ALUMINUM OXIDE
- BRYONIA ALBA ROOT
- ACTIVATED CHARCOAL
- CHELIDONIUM MAJUS
- GOLDENSEAL
- POTASSIUM CARBONATE
- CARBONATE ION
- LYCOPODIUM CLAVATUM SPORE
- MAGNESIUM CHLORIDE
- CHLORIDE ION
- DAPHNE MEZEREUM BARK
- SUCROSE
- STRYCHNOS NUX-VOMICA SEED
- PODOPHYLLUM
- KRAMERIA LAPPACEA ROOT
- SANICULA EUROPAEA LEAF
- SELENIUM
- SEPIA OFFICINALIS JUICE
- SILICON DIOXIDE
- TOBACCO LEAF
- VERATRUM ALBUM ROOT
- GRAPHITE
- IRIS VERSICOLOR ROOT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-1723 | 55714-1723-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Constipation | ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUM | Newton Laboratories, Inc. | 9d63b107-cd47-d9a5-e053-2a95a90a4493 | 2025-01-28 | Warnings | 55714-1723-1 55714-1723 55714172301 2cc87e76-e9af-66fa-e063-6394a90ab640 9d63b107-cd47-d9a5-e053-2a95a90a4493 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.