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
Active Ingredients** (in each pellet)
Aconitum napellus 6C HPUS (0.07 mg) (contains less than 10 -15 mg aconitine alkaloids)
Belladonna 6C HPUS (0.07 mg) (contains less than 10 -15 mg atropine alkaloids)
Calendula officinalis 6C HPUS (0.07 mg)
Chelidonium majus 6C HPUS (0.07 mg) (contains less than 10 -15 mg chelidonine alkaliods)
Jequirity 6C HPUS (0.07 mg) (contains less than 10 -14 indole alkaloids)
Viburnum opulus (0.07 mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Purpose*
Relieves Occasional Stress Symptoms: Nervous Tension, Irritability, Fatigue, and Uneasiness
Indications & Usage
Uses*
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 continuously 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 overdoes, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- Adults and children 12 years of age and older: Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved.
- Children under 12 years of age: Ask a doctor.
Inactive Ingredient
lactose, sucrose
Other
do not use if glued carton end flaps are open or if pellet dispenser seal is broken
contains 0.25 g of sugar per dose
Multi-Symptom
Stress Relief*
Plant-powered Relief
Meltaway Pellets
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Tube - Contains approx. 80 pellets, 3.8 g (0.13 oz)
Turn tube upside down
Twist until 5 pellets are dispensed
Remove cap and pour pellets under the tongue
Do not use if pellet dispenser seal is broken.
*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.
Otc - Questions
BoironUSA.com
1-800-264-7661
Made in France
Disbributed by
Boiron, Inc.
Newtown Square, PA
19073
* Please review the disclaimer below.