Restless 2349P-Dis

Drug Labeling and Warnings

Drug Details [pdf]

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 pellet 
Newton Laboratories, Inc.

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.

----------

Restless 2349P-Dis

INDICATIONS & USAGE SECTION

Restless Leg  Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching, trembling and numbness .

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

Mygale 15x, Agaricus musc. 10x, Causticum 10x, Cinchona 10x, Conium 10x, Cuprum met. 10x, Gelsemium 10x, Hyoscyamus 10x, Hypericum 10x, Kali carb. 10x ,Mag. carb. 10x, Merc. viv. 10x, Nux vom. 10x, Plumb. met. 10x, Rhus toxicodendron 10x, Secale 10x, Strychninum 10x, Tarentula hispana 10x, Valeriana 10x, Verbascum 10x, Zinc. met. 10x, Chamomilla 3x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching, trembling and numbness .

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

package 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 pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2349
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY10 [hp_X]  in 1 g
AVICULARIA AVICULARIA (UNII: 8ZTK6T93B6) (AVICULARIA AVICULARIA - UNII:8ZTK6T93B6) AVICULARIA AVICULARIA15 [hp_X]  in 1 g
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 1 g
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP10 [hp_X]  in 1 g
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER10 [hp_X]  in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 1 g
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER10 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM10 [hp_X]  in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE10 [hp_X]  in 1 g
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE10 [hp_X]  in 1 g
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY10 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 1 g
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD10 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 1 g
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM10 [hp_X]  in 1 g
STRYCHNINE (UNII: H9Y79VD43J) (STRYCHNINE - UNII:H9Y79VD43J) STRYCHNINE10 [hp_X]  in 1 g
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA10 [hp_X]  in 1 g
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN10 [hp_X]  in 1 g
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS10 [hp_X]  in 1 g
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1 g
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2349-128.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
2NDC: 55714-2349-256.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
3NDC: 55714-2349-07.08 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2349)

Revised: 1/2019
Document Id: 9262f2c3-fa91-a023-e053-2995a90a078f
Set id: 725509bf-e1e6-bf60-bd2e-014219ba8327
Version: 3
Effective Time: 20190131