FDA Label for Arnicare Leg Cramps
View Indications, Usage & Precautions
Arnicare Leg Cramps Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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.
Otc - 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
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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
Otc - Questions
Questions or comments?
Arnicare.com
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
Other
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
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.
* Please review the disclaimer below.