Label: STRESSCALM- aconitum napellus whole, atropa belladonna, calendula officinalis flowering top, chelidonium majus whole, abrus precatorius seed, viburnum opulus bark tablet
- NDC Code(s): 0220-9333-04, 0220-9333-29, 0220-9333-91
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients** (in each tablet)
Aconitum napellus 6C HPUS (0.4 mg) (contains less than 10 -14 mg aconitine alkaloids)
Belladonna 6C HPUS (0.4 mg) (contains less than 10 -14 mg atropine alkaloids)
Calendula officinalis 6C HPUS (0.4 mg)
Chelidonium majus 6C HPUS (0.4 mg) (contains less than 10- 14 mg chelidonine alkaloids)
Jequirity 6C HPUS (0.4 mg) (contains less 10 -14 mg indole alkaloids)
Viburnum opulus 6C HPUS (0.4mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
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PURPOSE
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 caused by stress
Jequirity 6C HPUS Relieves uneasiness
Viburnum opulus 6C HPUS Relieves nervousness and restless sleep
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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SPL UNCLASSIFIED SECTION
Do not use if glued carton end flaps are open or if the blister seal is broken.
store below 86°F (30°C)
contains 20 meltaway tablets unflavored
contains 60 meltaway tablets unflavored
contains 120 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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STRESSCALM
aconitum napellus whole, atropa belladonna, calendula officinalis flowering top, chelidonium majus whole, abrus precatorius seed, viburnum opulus bark tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9333 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK 6 [hp_C] ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 6 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 6 [hp_C] ABRUS PRECATORIUS SEED (UNII: 3OM8I6L7CD) (ABRUS PRECATORIUS SEED - UNII:3OM8I6L7CD) ABRUS PRECATORIUS SEED 6 [hp_C] CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_C] CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS WHOLE - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE 6 [hp_C] Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Boiron Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9333-04 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/14/2020 2 NDC:0220-9333-29 1 in 1 PACKAGE 04/02/2021 2 120 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0220-9333-91 1 in 1 PACKAGE 07/13/2021 3 20 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 09/14/2020 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9333)
