Label: RESTULEX RESTLESS LEG SYMPTOM RELIEF- arsenicum album, bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla, rhus toxicodendron, sulphur, tarentula hispana, viscum album, zincum metallicum liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49726-022-02 - Packager: Hello Life, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 December 26, 2018
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Active Ingredients (per dose)
Arsenicum album HPUS
Bufo rana HPUS
Causticum HPUS
Chamomilla HPUS
Crotalus horridus HPUS
Digitalis purpurea HPUS
Lachesis mutus HPUS
Lilium tigrinum HPUS
Pulsatilla HPUS
Rhus toxicodendron HPUS
Sulphur HPUS
Tarentula hispana HPUS
Viscum album HPUS
Zincum metallicum HPUS
Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica. -
Purpose
Arsenicum album HPUS..............................Twitching
Bufo rana HPUS...........................................Numbness of limbs
Causticum HPUS..........................................Pain
Chamomilla HPUS.......................................Rheumatic pains
Crotalus horridus HPUS..............................Cannot keep legs or feet still
Digitalis purpurea HPUS..............................Rheumatic pains
Lachesis mutus HPUS..................................Restlessness
Lilium tigrinum HPUS..................................Burning of feet
Pulsatilla HPUS............................................Jerking
Rhus toxicodendron HPUS..........................Tingling in feet
Sulphur HPUS..............................................Stiffness
Tarentula hispana HPUS..............................Extraordinary movements
Viscum album HPUS....................................Muscle tremors
Zincum metallicum HPUS............................Trembling
- Uses
- Warnings
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
Dispense Restulex directly into mouth, or add recommended dosage into 8-12 oz of purified (non-chlorinated) water and drink. Safe for ages 2 and up.
DOSAGE BY WEIGHT
30-50 lbs (13.6-22.6 kg) 1/2 mL twice per day
50+ lbs (22.6+ kg) 1 mL twice per day
External Use: If needed, apply to affected areas 2-6 times daily until symptoms improve.
- Other information
- Inactive ingredients
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- DESCRIPTION
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INGREDIENTS AND APPEARANCE
RESTULEX RESTLESS LEG SYMPTOM RELIEF
arsenicum album, bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla, rhus toxicodendron, sulphur, tarentula hispana, viscum album, zincum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49726-022 Route of Administration ORAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 10 [hp_X] in 59 mL BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND 10 [hp_X] in 59 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 10 [hp_X] in 59 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 59 mL CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM 10 [hp_X] in 59 mL DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS 10 [hp_X] in 59 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 10 [hp_X] in 59 mL LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917) (LILIUM LANCIFOLIUM FLOWERING TOP - UNII:6268MFA917) LILIUM LANCIFOLIUM FLOWERING TOP 10 [hp_X] in 59 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 10 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 59 mL LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA 10 [hp_X] in 59 mL VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 10 [hp_X] in 59 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49726-022-02 1 in 1 CARTON 11/09/2011 1 59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/09/2011 Labeler - Hello Life, Inc. (065619378) Establishment Name Address ID/FEI Business Operations Hello Life, Inc. 065619378 relabel(49726-022) , repack(49726-022) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(49726-022)
