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

Arnicare Leg Cramps by

Drug Labeling and Warnings

Arnicare Leg Cramps by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoires Boiron, Boiron Inc., Boiron. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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)