FDA Label for Stresscalm
View Indications, Usage & Precautions
Stresscalm Product Label
The following document was submitted to the FDA by the labeler of this product 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
Aconitum napellus 6C HPUS (0.4mg)** (in each tablet) (contains less than 10-14 mg aconitine alkaloids)
Belladonna 6C HPUS (0.4mg)** (in each tablet) (contains less than 10-14 mg atropine alkaloids)
Calendula officinalis 6C HPUS (0.4mg)** (in each tablet)
Chelidonium majus 6C HPUS (0.4mg) ** (in each tablet) (contains less than 10-14 mg chelidonine alkaloids)
Jequirity 6C HPUS (0.4mg) ** (in each tablet) (contains less 10-14 mg indole alkaloids)
Viburnum opulus 6C HPUS (0.4mg) ** (in each tablet)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Aconitum napellus 6C HPUS Relieves restlessness and agitation*
Belladonna 6C HPUS Relieves hypersensitivity to stress*
Calendula officinalis 6C HPUS Relieves nervous fatigue, hypersensitivity to noise*
Chelidonium majus 6C HPUS Relieves digestive symptoms cause by stress*
Jequirity 6C HPUS Relieves uneasiness*
Viburnum opulus 6C HPUS Relieves nervousness and restless sleep*
Indications & Usage
*temporarily relieves symptoms of occasional stress such as: nervous tension, fatigue, digestive symptoms caused by stress, hypersensitivity to stress or noise, irritability, uneasiness, does not affect alertness
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 2 weeks or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 12 years of age and older: At the onset of symptoms, dissolve 2 tablets under the tongue 3 times a day until symptoms are relieved.
Children under 12 years of age: Ask a doctor.
Other
Do not use if glued carton end flaps are open or if the blister seal is broken.
store below 86oF (30oC)
contains 60 meltaway tablets unflavored
Stress Relief*
Reduces Nervous Tension*
Calms Mind & Body*
Stay focused & relaxed
Plant-based Actives
Non-Drowsy
Meltaway tablets require no food or water
No artificial colors, flavors, or sweeteners
Non-habit forming
No known drug interactions
*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.
Inactive Ingredient
croscarmellose sodium, lactose, magnesium stearate
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
* Please review the disclaimer below.