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 July 1, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
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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
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
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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
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INGREDIENTS AND APPEARANCE
ARNICARE LEG CRAMPS
arnica montana whole, copper, magnesium phosphate, dibasic trihydrate, strychnos nux-vomica seed, passiflora incarnata top, claviceps purpurea sclerotium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9079 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP 3 [hp_X] COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 4 [hp_C] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_C] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_C] CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM 9 [hp_C] Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color white Score score with uneven pieces Shape ROUND Size 9mm Flavor Imprint Code Boiron Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9079-04 1 in 1 CARTON 09/11/2023 1 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0220-9079-29 1 in 1 CARTON 11/07/2023 2 120 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/11/2023 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9079)