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#

ProductLeg Cramps - Swelling
Active ingredientMicrurus Corallinus Venom, Silver Nitrate, 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, Echinacea, Unspecified
Label structure10 sections

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

OTC - 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2295-02020-01-31C16284748780-19d75b9d0-2aa9-f424-e053-dadaa90a57ceLeg Cramps - Swelling
55714-2295-12020-01-31C16284748780-19d75b9d0-2aa9-f424-e053-dadaa90a57ceLeg Cramps - Swelling
55714-2295-22020-01-31C16284748780-19d75b9d0-2aa9-f424-e053-dadaa90a57ceLeg Cramps - Swelling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2295-0Leg Cramps - Swelling7.08 g in 1 BOTTLE, GLASSPELLET7.081
55714-2295-1Leg Cramps - Swelling28.35 g in 1 BOTTLE, GLASSPELLET28.351
55714-2295-2Leg Cramps - Swelling56.7 g in 1 BOTTLE, GLASSPELLET56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2295LEG 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.]1Legacy NDC, 3 package rows20131015_37328986-2a95-cf58-52ac-8b0b796a433b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Citrullus Colocynthis Fruit PulpACTIVE INGREDIENT23H32AOH171
Convallaria MajalisACTIVE INGREDIENTQHH4HVF5QE1
CopperACTIVE INGREDIENT789U1901C51
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9561
Datura StramoniumACTIVE INGREDIENTG6W4F0V8Z31
DigitalisACTIVE INGREDIENTF1T8QT9U8B1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lathyrus Sativas SeedACTIVE INGREDIENT8VP54WOT4I1
Lilium Lancifolium Whole FloweringACTIVE INGREDIENTX67Z2963PI1
Magnesium Phosphate, Dibasic TrihydrateACTIVE INGREDIENTHF539G9L3Q1
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369801
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I1
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA1
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU41
Silver NitrateACTIVE INGREDIENT95IT3W8JZE1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Veratrum Viride RootACTIVE INGREDIENT197B3Q7T5Q1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
Citrullus Colocynthis Fruit PulpACTIVE MOIETY23H32AOH171
Convallaria MajalisACTIVE MOIETYQHH4HVF5QE1
CopperACTIVE MOIETY789U1901C51
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9561
Datura StramoniumACTIVE MOIETYG6W4F0V8Z31
DigitalisACTIVE MOIETYF1T8QT9U8B1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lathyrus Sativas SeedACTIVE MOIETY8VP54WOT4I1
Lilium Lancifolium Whole FloweringACTIVE MOIETYX67Z2963PI1
Magnesium CationACTIVE MOIETYT6V3LHY8381
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369801
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I1
Silicon DioxideACTIVE MOIETYETJ7Z6XBU41
Silver CationACTIVE MOIETY57N7B0K90A1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Veratrum Viride RootACTIVE MOIETY197B3Q7T5Q1
SucroseINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-229555714-2295-1, 55714-2295-2, 55714-2295-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates

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
845c979e-a9fc-9f1f-20d7-70cbed00044f37328986-2a95-cf58-52ac-8b0b796a433b2011-03-01WarningsExact identifier
spl id: 845c979e-a9fc-9f1f-20d7-70cbed00044f
spl set id: 37328986-2a95-cf58-52ac-8b0b796a433b

Reported adverse events (FAERS/openFDA)#

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