Leg Cramps-Swelling
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2023-11-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:23:02
Label at a glance#
ProductLeg Cramps-Swelling
Active ingredientECHINACEA, UNSPECIFIED, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CITRULLUS COLOCYNTHIS FRUIT PULP, CONVALLARIA MAJALIS, CROTALUS HORRIDUS HORRIDUS VENOM, COPPER, DIGITALIS, GELSEMIUM SEMPERVIRENS ROOT, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, LATHYRUS SATIVAS SEED, LILIUM LANCIFOLIUM WHOLE FLOWERING, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, DATURA STRAMONIUM, VERATRUM VIRIDE ROOT, MICRURUS CORALLINUS VENOM, SILVER NITRATE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as pain, cramping, swelling, inflammation and stiffness in the legs and feet.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Argentum nitricum15x, Bryonia 15x, Calcarea carbonica 15x, Colocynthis 15x, Convallaria majalis 15x, Crotalus horridus 15x, Cuprum metallicum 15x, Digitalis purpurea 15x, Gelsemium sempervirens 15x, Hypericum perforatum 15x, Kali carbonicum 15x, Lachesis mutus 15x, Lathyrus sativus 15x, Lilium tigrinum 15x, Magnesia phosphorica 15x, Nux vomica 15x, Rhus toxicodendron 15x, Silicea 15x, Stramonium 15x, Veratrum viride 15x, Elaps corallinus 30x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as pain, cramping, swelling, inflammation and stiffness in the legs and feet.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: 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
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-2474-1 | 2023-11-03 | C162847 | 48780-1 | d6a99b39-36e0-a426-e053-dadaa90af4c2 | Leg 2474P |
| 55714-2474-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-36e0-a426-e053-dadaa90af4c2 | Leg 2474P |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2474-1 | Leg Cramps-Swelling | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2474 | LEG CRAMPS-SWELLING (ECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPS) PELLET [NEWTON LABORATORIES, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231104_9c31d465-caac-3a02-e053-2a95a90adb3b.zip |
Products#
Every source-derived product name is available through these pages.
- Leg Cramps-Swelling
- Echinacea, Argentum nitricum, Bryonia, Calcarea carbonica, Colocynthis, Convallaria majalis, Crotalus horridus, Cuprum metallicum, Digitalis , Gelsemium sempervirens, Hypericum perforatum, Kali carbonicum, Lachesis mutus, Lathyrus sativus, Lilium tigrinum, Magnesia phosphorica, Nux vomica, Rhus toxicodendron, Silicea, Stramonium, Veratrum viride, Elaps
- SUCROSE
- ECHINACEA, UNSPECIFIED
- BRYONIA ALBA ROOT
- OYSTER SHELL CALCIUM CARBONATE, CRUDE
- CITRULLUS COLOCYNTHIS FRUIT PULP
- CONVALLARIA MAJALIS
- CROTALUS HORRIDUS HORRIDUS VENOM
- COPPER
- DIGITALIS
- GELSEMIUM SEMPERVIRENS ROOT
- HYPERICUM PERFORATUM
- POTASSIUM CARBONATE
- CARBONATE ION
- LACHESIS MUTA VENOM
- LATHYRUS SATIVAS SEED
- LILIUM LANCIFOLIUM WHOLE FLOWERING
- MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- MAGNESIUM CATION
- STRYCHNOS NUX-VOMICA SEED
- TOXICODENDRON PUBESCENS LEAF
- SILICON DIOXIDE
- DATURA STRAMONIUM
- VERATRUM VIRIDE ROOT
- MICRURUS CORALLINUS VENOM
- SILVER NITRATE
- SILVER CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2474 | 55714-2474-1 |
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 |
|---|---|---|---|---|---|---|
| Leg Cramps-Swelling | ECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPS | Newton Laboratories, Inc. | 9c31d465-caac-3a02-e053-2a95a90adb3b | 2023-11-03 | Warnings | 55714-2474-1 55714-2474 55714247401 09425ade-9c7f-ca75-e063-6294a90a8c9a 9c31d465-caac-3a02-e053-2a95a90adb3b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.