Label: RESTLESS LEG- mygale, agaricus musc., causticum, cinchona, conium, cuprum met., gelsemium, hyoscyamus, hypericum, kali carb., mag. carb., merc. viv., nux vom., plumb. met., rhus toxicodendron, secale, strychninum, tarentula hispana, valeriana, verbascum, zinc. met., chamomilla,passiflora liquid
- NDC Code(s): 55714-2554-1
- Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 2, 2020
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Chamomilla 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Agaricus muscarius 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Cuprum metallicum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Kali carbonicum 15x, Magnesia carbonica 15x, Mercurius vivus 15x, Nux vomica 15x, Plumbum metallicum 15x, Rhus toxicodendron 15x, Secale cornutum 15x, Strychninum 15x, Tarentula hispana 15x, Valeriana officinalis 15x, Verbascum thapsus 15x, Zincum metallicum 15x, Mygale 16x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
RESTLESS LEG
mygale, agaricus musc., causticum, cinchona, conium, cuprum met., gelsemium, hyoscyamus, hypericum, kali carb., mag. carb., merc. viv., nux vom., plumb. met., rhus toxicodendron, secale, strychninum, tarentula hispana, valeriana, verbascum, zinc. met., chamomilla,passiflora liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2554 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY 15 [hp_X] in 1 mL AVICULARIA AVICULARIA (UNII: 8ZTK6T93B6) (AVICULARIA AVICULARIA - UNII:8ZTK6T93B6) AVICULARIA AVICULARIA 16 [hp_X] in 1 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 15 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 15 [hp_X] in 1 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 15 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X] in 1 mL HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 15 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 15 [hp_X] in 1 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 15 [hp_X] in 1 mL MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 15 [hp_X] in 1 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 15 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD 15 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 mL CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM 15 [hp_X] in 1 mL STRYCHNINE (UNII: H9Y79VD43J) (STRYCHNINE - UNII:H9Y79VD43J) STRYCHNINE 15 [hp_X] in 1 mL LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA 15 [hp_X] in 1 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 15 [hp_X] in 1 mL VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS 15 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 15 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2554-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-2554)