Label: STRESSCALM- aconitum napellus, atropa belladonna, chelidonium majus, calendula officinalis flowering top, viburnum opulus bark, abrus precatorius seed pellet
- NDC Code(s): 0220-9334-41, 0220-9334-42
- Packager: 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 April 5, 2023
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 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 6C HPUS (0.07 mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
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. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STRESSCALM
aconitum napellus, atropa belladonna, chelidonium majus, calendula officinalis flowering top, viburnum opulus bark, abrus precatorius seed pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9334 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 6 [hp_C] CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 6 [hp_C] CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_C] ABRUS PRECATORIUS SEED (UNII: 3OM8I6L7CD) (ABRUS PRECATORIUS SEED - UNII:3OM8I6L7CD) ABRUS PRECATORIUS SEED 6 [hp_C] VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK 6 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9334-42 2 in 1 BOX 04/29/2022 1 NDC:0220-9334-41 80 in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/29/2022 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9334)
