Label: LEG CRAMPS- cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top tablet, soluble
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NDC Code(s):
54973-3114-1,
54973-3114-2,
54973-3114-3,
54973-3114-4, view more54973-3114-5, 54973-3114-7
- 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)
- PURPOSE
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Drug Facts
Active ingredients Purpose Aconitum Napellus 6X HPUS pains in joints and legs Cinchona Officinalis 3X HPUS pains in limbs and joints; cramping in legs Gnaphalium Polycephalum 3X HPUS cramps in calves and feet Ledum Palustre 6X HPUS pain and cramps in legs Magnesia Phosphorica 6X HPUS muscle cramps Rhus Toxicodendron 6X HPUS pain and stiffness Viscum Album 3X HPUS pains in joints "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Warnings
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Directions
■ Use as directed.
Adults and children
12 years and overAt onset of symptoms, swallow 1-2 caplets with water every 4 hours as needed. If the initial dosage is not providing immediate relief, swallow 1-2 caplets with water every 15 minutes until relieved, up to 6 doses. Children under
12 years of ageAsk a doctor before use. - Inactive ingredients
- Questions?
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
- Uses
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
LEG CRAMPS
cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top tablet, solubleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3114 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 3 [hp_X] ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_X] PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM 3 [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 3 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3114-3 3 in 1 CARTON 12/04/1995 1 NDC:54973-3114-1 4 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:54973-3114-2 1 in 1 CARTON 12/04/1995 2 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:54973-3114-4 1 in 1 CARTON 12/04/1995 3 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:54973-3114-5 1 in 1 CARTON 12/04/1995 4 16 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:54973-3114-7 1 in 1 CARTON 12/04/1995 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 12/04/1995 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Reed-Lane, Inc. 001819879 pack(54973-3114) Establishment Name Address ID/FEI Business Operations Hyland's Consumer Health Inc 008316655 manufacture(54973-3114) , pack(54973-3114) , label(54973-3114) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(54973-3114) Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 manufacture(54973-3114) , pack(54973-3114) , label(54973-3114)