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

package label

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2474
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X] in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X] in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	15 [hp_X] in 1 g
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	15 [hp_X] in 1 g
CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE)	CONVALLARIA MAJALIS	15 [hp_X] in 1 g
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956)	CROTALUS HORRIDUS HORRIDUS VENOM	15 [hp_X] in 1 g
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	15 [hp_X] in 1 g
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	15 [hp_X] in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	15 [hp_X] in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	15 [hp_X] in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	15 [hp_X] in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [hp_X] in 1 g
LATHYRUS SATIVAS SEED (UNII: 8VP54WOT4I) (LATHYRUS SATIVAS SEED - UNII:8VP54WOT4I)	LATHYRUS SATIVAS SEED	15 [hp_X] in 1 g
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	15 [hp_X] in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	15 [hp_X] in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X] in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X] in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 [hp_X] in 1 g
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	15 [hp_X] in 1 g
VERATRUM VIRIDE ROOT (UNII: 197B3Q7T5Q) (VERATRUM VIRIDE ROOT - UNII:197B3Q7T5Q)	VERATRUM VIRIDE ROOT	15 [hp_X] in 1 g
MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980)	MICRURUS CORALLINUS VENOM	30 [hp_X] in 1 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	15 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-2474-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2474)

Leg 2474P