Leg Cramps - Swelling
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-03-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:00
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Leg Cramps - Swelling Formulated for associated symptoms such as pain, cramping, swelling due to inflammation, stiffness and numbness in the legs and feet.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Elaps corallinus 30x, Arg. nit. 15x, Bryonia 15x, Calc. carb. 15x, Colocynthis 15x, Convallaria 15x, Crotalus horridus 15x, Cuprum met. 15x, Digitalis 15x, Gelsemium 15x, Hypericum 15x, Kali carb. 15x, Lachesis 15x, Lathyrus sativus 15x, Lilium 15x, Mag. phos. 15x, Nux vom. 15x, Rhus toxicodendron 15x, Silicea 15x, Stramonium 15x, Veratrum viride 15x, Echinacea 3x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as pain, cramping, swelling due to inflammation, stiffness and numbness in the legs and feet.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
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 |
|---|---|---|---|---|---|
| 55714-2295-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2aa9-f424-e053-dadaa90a57ce | Leg Cramps - Swelling |
| 55714-2295-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2aa9-f424-e053-dadaa90a57ce | Leg Cramps - Swelling |
| 55714-2295-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2aa9-f424-e053-dadaa90a57ce | Leg Cramps - Swelling |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2295-0 | Leg Cramps - Swelling | 7.08 g in 1 BOTTLE, GLASS | PELLET | 7.08 | 1 | |
| 55714-2295-1 | Leg Cramps - Swelling | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-2295-2 | Leg Cramps - Swelling | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2295 | LEG CRAMPS - SWELLING (ELAPS CORALLINUS, ARG. NIT., BRYONIA, CALC. CARB., COLOCYNTHIS, CONVALLARIA, CROTALUS HORRIDUS, CUPRUM MET., DIGITALIS, GELSEMIUM, HYPERICUM, KALI CARB., LACHESIS, LATHYRUS SATIVUS, LILIUM, MAG. PHOS., NUX VOM., RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ECHINACEA) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 3 package rows | 20131015_37328986-2a95-cf58-52ac-8b0b796a433b.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Citrullus Colocynthis Fruit Pulp | ACTIVE INGREDIENT | 23H32AOH17 | 1 | |
| Convallaria Majalis | ACTIVE INGREDIENT | QHH4HVF5QE | 1 | |
| Copper | ACTIVE INGREDIENT | 789U1901C5 | 1 | |
| Crotalus Horridus Horridus Venom | ACTIVE INGREDIENT | YHA2XLJ956 | 1 | |
| Datura Stramonium | ACTIVE INGREDIENT | G6W4F0V8Z3 | 1 | |
| Digitalis | ACTIVE INGREDIENT | F1T8QT9U8B | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| Gelsemium Sempervirens Root | ACTIVE INGREDIENT | 639KR60Q1Q | 1 | |
| Hypericum Perforatum | ACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| Lachesis Muta Venom | ACTIVE INGREDIENT | VSW71SS07I | 1 | |
| Lathyrus Sativas Seed | ACTIVE INGREDIENT | 8VP54WOT4I | 1 | |
| Lilium Lancifolium Whole Flowering | ACTIVE INGREDIENT | X67Z2963PI | 1 | |
| Magnesium Phosphate, Dibasic Trihydrate | ACTIVE INGREDIENT | HF539G9L3Q | 1 | |
| Micrurus Corallinus Venom | ACTIVE INGREDIENT | V0S6H36980 | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE INGREDIENT | 2E32821G6I | 1 | |
| Potassium Carbonate | ACTIVE INGREDIENT | BQN1B9B9HA | 1 | |
| Silicon Dioxide | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Silver Nitrate | ACTIVE INGREDIENT | 95IT3W8JZE | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Toxicodendron Pubescens Leaf | ACTIVE INGREDIENT | 6IO182RP7A | 1 | |
| Veratrum Viride Root | ACTIVE INGREDIENT | 197B3Q7T5Q | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Carbonate Ion | ACTIVE MOIETY | 7UJQ5OPE7D | 1 | |
| Citrullus Colocynthis Fruit Pulp | ACTIVE MOIETY | 23H32AOH17 | 1 | |
| Convallaria Majalis | ACTIVE MOIETY | QHH4HVF5QE | 1 | |
| Copper | ACTIVE MOIETY | 789U1901C5 | 1 | |
| Crotalus Horridus Horridus Venom | ACTIVE MOIETY | YHA2XLJ956 | 1 | |
| Datura Stramonium | ACTIVE MOIETY | G6W4F0V8Z3 | 1 | |
| Digitalis | ACTIVE MOIETY | F1T8QT9U8B | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| Gelsemium Sempervirens Root | ACTIVE MOIETY | 639KR60Q1Q | 1 | |
| Hypericum Perforatum | ACTIVE MOIETY | XK4IUX8MNB | 1 | |
| Lachesis Muta Venom | ACTIVE MOIETY | VSW71SS07I | 1 | |
| Lathyrus Sativas Seed | ACTIVE MOIETY | 8VP54WOT4I | 1 | |
| Lilium Lancifolium Whole Flowering | ACTIVE MOIETY | X67Z2963PI | 1 | |
| Magnesium Cation | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| Micrurus Corallinus Venom | ACTIVE MOIETY | V0S6H36980 | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE MOIETY | 2E32821G6I | 1 | |
| Silicon Dioxide | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| Silver Cation | ACTIVE MOIETY | 57N7B0K90A | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Toxicodendron Pubescens Leaf | ACTIVE MOIETY | 6IO182RP7A | 1 | |
| Veratrum Viride Root | ACTIVE MOIETY | 197B3Q7T5Q | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Leg Cramps - Swelling
- Elaps corallinus, Arg. nit., Bryonia, Calc. carb., Colocynthis, Convallaria, Crotalus horridus, Cuprum met., Digitalis, Gelsemium, Hypericum, Kali carb., Lachesis, Lathyrus sativus, Lilium, Mag. phos., Nux vom., Rhus toxicodendron, Silicea, Stramonium, Veratrum viride, Echinacea
- Micrurus Corallinus Venom
- Silver Nitrate
- Silver Cation
- 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
- Echinacea, Unspecified
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2295 | 55714-2295-1, 55714-2295-2, 55714-2295-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v |
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 |
|---|---|---|---|---|---|---|
| 845c979e-a9fc-9f1f-20d7-70cbed00044f | 37328986-2a95-cf58-52ac-8b0b796a433b | 2011-03-01 | Warnings | 845c979e-a9fc-9f1f-20d7-70cbed00044f 37328986-2a95-cf58-52ac-8b0b796a433b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
