Label: RESTFUL LEGS PM- anemone patens,matricaria chamomilla,sulfur,zinc,toxicodendron pubescens leaf,arsenic trioxide,arabica coffee bean,lycopodium clavatum spore tablet
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NDC Code(s):
54973-3352-1,
54973-3352-2,
54973-3352-3,
54973-3352-4, view more54973-3352-5
- Packager: Hyland's 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 November 2, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Drug Facts
Active Ingredients
Arsenicum Album 12X HPUS
Chamomilla 3X HPUS
Coffea Cruda 3X HPUS
Lycopodium 6X HPUS
Pulsatilla 6X HPUS
Rhus Toxicodendron 6X HPUS
Sulphur 6X HPUS
Zincum Metallicum 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
- Warnings
- Directions
- Inactive Ingredients
- Questions?
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- **THIS PRODUCT IS NOT INTENDED TO TREAT RESTLESS LEG SYNDROME.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
RESTFUL LEGS PM
anemone patens,matricaria chamomilla,sulfur,zinc,toxicodendron pubescens leaf,arsenic trioxide,arabica coffee bean,lycopodium clavatum spore tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3352 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 3 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 12 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE 6 [hp_X] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white (Off-White to Light Beige) Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3352-1 1 in 1 CARTON 03/14/2018 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3352-2 4 in 1 PACKET; Type 0: Not a Combination Product 03/14/2018 3 NDC:54973-3352-3 1 in 1 CARTON 03/14/2018 12/29/2021 3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:54973-3352-4 1 in 1 CARTON 03/14/2018 4 16 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:54973-3352-5 1 in 1 CARTON 03/14/2018 5 16 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/14/2018 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Consumer Health Inc. 008316655 pack(54973-3352) , label(54973-3352) , manufacture(54973-3352)