Label: RESTLESS LEGS RELIEF- aconitum napellus, gnaphalium polycephalum, ledum palustre, magnesia phosphorica, rhus toxicodendron, viscum album tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 57520-0450-1 - Packager: Apotheca Company
- 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 11, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
WARNINGS: Use only as directed.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing.
Other Information: Store tightly closed in a cool dry place (59 to 86 F)
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DOSAGE & ADMINISTRATION
DIRECTIONS: Adults dissolve 2 tablets under tongue twice a day.
Can be increased to 2 tablets 3 times a day, if needed.
For stubborn cases, take 1-2 tablets every 4 hours.
For children 12 and under, consult a health professional.
For maximum effectiveness, take tablets regularly and consistently.
Regular use will generally result in a positive effect within 4-6 weeks, although many people respond even sooner.
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RESTLESS LEGS RELIEF
aconitum napellus, gnaphalium polycephalum, ledum palustre, magnesia phosphorica, rhus toxicodendron, viscum album tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57520-0450 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_X] PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM 4 [hp_X] LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [hp_X] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 4 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white (white) Score no score Shape ROUND (round) Size 6mm Flavor Imprint Code Diamond Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57520-0450-1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/11/2010 Labeler - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture
