Stresscalm

Stresscalm
SPL v5
SPL
SPL Set ID af489aa8-9737-33e1-e053-2995a90ad280
Route
ORAL
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Viburnum Opulus Bark (6 [hp_C]) Aconitum Napellus Whole Atropa Belladonna Abrus Precatorius Seed Calendula Officinalis Flowering Top Chelidonium Majus Whole
Inactive Ingredients
Magnesium Stearate Lactose, Unspecified Form Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: Boiron Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-09-14

Description

Active ingredients** (in each tablet) Aconitum napellus 6C HPUS (0.42 mg) (contains less than 10 -14 mg aconitine alkaloids) Belladonna 6C HPUS (0.42 mg) (contains less than 10 -14 mg atropine alkaloids) Calendula officinalis 6C HPUS (0.42 mg) Chelidonium majus 6C HPUS (0.43 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.


Medication Information

Indications and 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

Dosage and Administration

Directions

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.

Description

Active ingredients** (in each tablet) Aconitum napellus 6C HPUS (0.42 mg) (contains less than 10 -14 mg aconitine alkaloids) Belladonna 6C HPUS (0.42 mg) (contains less than 10 -14 mg atropine alkaloids) Calendula officinalis 6C HPUS (0.42 mg) Chelidonium majus 6C HPUS (0.43 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.

Section 42229-5

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 100 meltaway tablets unflavored

contains 120 meltaway tablets unflavored

Stress Relief*

Relieves Nervous Tension Calms Mind & Body*

Non-Drowsy

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.

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist for more than 2 weeks or worsen.

Section 51727-6

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

Questions or comments?

1-800-BOIRON-1 (1-800-264-7661),

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

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

Section 55106-9

Active ingredients** (in each tablet)

Aconitum napellus 6C HPUS (0.42 mg) (contains less than 10 -14 mg aconitine alkaloids)

Belladonna 6C HPUS (0.42 mg) (contains less than 10 -14 mg atropine alkaloids)

Calendula officinalis 6C HPUS (0.42 mg)

Chelidonium majus 6C HPUS (0.43 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.


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

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.

Section 42229-5 (42229-5)

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 100 meltaway tablets unflavored

contains 120 meltaway tablets unflavored

Stress Relief*

Relieves Nervous Tension Calms Mind & Body*

Non-Drowsy

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.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist for more than 2 weeks or worsen.

Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-BOIRON-1 (1-800-264-7661),

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Active ingredients** (in each tablet)

Aconitum napellus 6C HPUS (0.42 mg) (contains less than 10 -14 mg aconitine alkaloids)

Belladonna 6C HPUS (0.42 mg) (contains less than 10 -14 mg atropine alkaloids)

Calendula officinalis 6C HPUS (0.42 mg)

Chelidonium majus 6C HPUS (0.43 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.


Advanced Ingredient Data


Raw Label Data

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