Label: ARNICARE LEG CRAMPS- arnica montana whole, copper, magnesium phosphate, dibasic trihydrate, strychnos nux-vomica seed, passiflora incarnata top, claviceps purpurea sclerotium tablet

  • NDC Code(s): 0220-9079-04, 0220-9079-29
  • Packager: Laboratoires Boiron
  • 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 7, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients** (in each tablet)

    Arnica montana 6C HPUS (0.42 mg)

    Cuprum metallicum 4C HPUS (0.42 mg)

    Magnesia phosphorica 6C HPUS (0.42 mg)

    Nux vomica 6C HPUS (0.42 mg) (contains less than 10 -13 mg strychnine alkaloids)

    Passiflora incarnata 3X HPUS (0.42 mg)

    Secale cornutum 9C HPUS (0.42 mg) (contains less thank 10 -20 mg ergotamine alkaloids)

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Purpose*

    Arnica montana 6C HPUS ... Temporarily relieves minor muscle pain

    Cuprum metallicum 4C HPUS ... Relieves sudden muscle cramps in the legs, calves, feet, and toes

    Magnesia phosphorica 6C HPUS ... Relieves flashing pain and cramps in the calves and thighs, at night

    Nux vomica 6C HPUS ... Relieves cramps in the legs, thighs, calves and toes, at night

    Passiflora incarnata 3X HPUS ... Helps to fall back asleep

    Secale cornutum 9C HPUS ... Relieves leg cramps at night

  • INDICATIONS & USAGE

    Uses* temporarily relieves nighttime cramps in legs, thighs, calves, feet, and toes with accompanying occasional disrupted sleep

  • WARNINGS

  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • Adults and children 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth at bedtime and during the night if needed, for up to 6 times per 24 hours.
    • Children under 18 years of age: Not recommended.
  • INACTIVE INGREDIENT

    croscarmellose sodium, lactose, magnesium stearate

  • QUESTIONS

    Questions or comments?

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Made in France

    Distributed by Boiron, Inc.

    Newtown Square, PA 19073

  • SPL UNCLASSIFIED SECTION

    do not use if glued carton end flaps are open or if the blister seal is broken

    store below 86 oF (30 oC)

    60 Meltaway Tablets, unflavored

    120 Meltaway Tablets, unflavored

    Nighttime Leg Cramp Relief*

    Plant-Based & Other Pure Actives

    Non-Habit Forming

    No Known Drug Interactions

    No Artificial Sweeteners, Flavors, Colors or Preservatives

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • PRINCIPAL DISPLAY PANEL

    labellabellabellabel

  • INGREDIENTS AND APPEARANCE
    ARNICARE LEG CRAMPS 
    arnica montana whole, copper, magnesium phosphate, dibasic trihydrate, strychnos nux-vomica seed, passiflora incarnata top, claviceps purpurea sclerotium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9079
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP3 [hp_X]
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER4 [hp_C]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_C]
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM9 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize9mm
    FlavorImprint Code Boiron
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9079-041 in 1 CARTON09/11/2023
    160 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0220-9079-291 in 1 CARTON11/07/2023
    2120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/11/2023
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9079)