Sedalia

Drug Facts

Composition & Product

Active Ingredients

Aconitum Napellus (6 [hp_C]) Belladonna Leaf Calendula Officinalis Flowering Top Chelidonium Majus Abrus Precatorius Seed Viburnum Opulus Bark

Inactive Ingredients

Croscarmellose Sodium Lactose Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: ; Shape: round Color: white Size: 9 mm Score: 1

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 1997-07-05

Medication Information

Warnings and Precautions

Indications and Usage

For temporary relief of nervousness, hypersensitivity and irritability due to stress.

Dosage and Administration

Adult and children 12 years of age and older: dissolve 2 tablets in the mouth 3 times a day.

Dosage Forms and Strengths

60 tablets

Description

Directions: (adults and children 12 years of age and older): Allow 3 tablets to dissolve in the mouth 3 times a day.

Section 34073-7

Non habit forming, no drug interactions

Section 44425-7

Store at 68-77 ^o F (20-25 ^o C)

Section 50565-1

Keep out of reach of children

Section 50566-9

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

Section 50567-7

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

Section 50569-3

Ask a doctor before use in children younger than 12 years of age.

Section 51727-6

Croscarmellose sodium, lactose, magnesium stearate.

Section 51945-4

Section 53413-1

Questions, Comments

www.boironusa.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Boiron Information Center

6 campus Bouelvard

Newtown Square, PA

19073-3267

Section 55105-1

Aconitum napellus 6C Relieves restlessness, agitation

Belladona 6C Relieves hypersensitivity to stress

Calendula officinalis 6C Relieves nervous fatigue, hypersensitivity to noise

Chelidonium majus 6C Relieves digestive symptoms caused by stress

Jequirity 6C Relieves uneasiness

Viburnum opulus 6C Relieves nervousness and restless sleep

Section 55106-9

Aconitum napellus 6C, Belladona 6C, Calendula officinalis 6C, Chelidonium majus 6C, Jequirity 6C, Viburnum opulus 6C

Structured Label Content

Indications and Usage (34067-9)

For temporary relief of nervousness, hypersensitivity and irritability due to stress.

Dosage and Administration (34068-7)

Adult and children 12 years of age and older: dissolve 2 tablets in the mouth 3 times a day.

Dosage Forms and Strengths (34069-5)

60 tablets

Warnings and Precautions (34071-1)

Section 34073-7 (34073-7)

Non habit forming, no drug interactions

Description (34089-3)

Directions: (adults and children 12 years of age and older): Allow 3 tablets to dissolve in the mouth 3 times a day.

Section 44425-7 (44425-7)

Store at 68-77 ^o F (20-25 ^o C)

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Ask a doctor before use in children younger than 12 years of age.

Section 51727-6 (51727-6)

Croscarmellose sodium, lactose, magnesium stearate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions, Comments

www.boironusa.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Boiron Information Center

6 campus Bouelvard

Newtown Square, PA

19073-3267

Section 55105-1 (55105-1)

Aconitum napellus 6C Relieves restlessness, agitation

Belladona 6C Relieves hypersensitivity to stress

Calendula officinalis 6C Relieves nervous fatigue, hypersensitivity to noise

Chelidonium majus 6C Relieves digestive symptoms caused by stress

Jequirity 6C Relieves uneasiness

Viburnum opulus 6C Relieves nervousness and restless sleep

Section 55106-9 (55106-9)

Aconitum napellus 6C, Belladona 6C, Calendula officinalis 6C, Chelidonium majus 6C, Jequirity 6C, Viburnum opulus 6C

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACONITUM NAPELLUS", "unii": "U0NQ8555JD", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "BELLADONNA LEAF", "unii": "6GZW20TIOI", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "CALENDULA OFFICINALIS FLOWERING TOP", "unii": "18E7415PXQ", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "CHELIDONIUM MAJUS", "unii": "7E889U5RNN", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "ABRUS PRECATORIUS SEED", "unii": "3OM8I6L7CD", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "VIBURNUM OPULUS BARK", "unii": "T1UG6H6805", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For temporary relief of nervousness, hypersensitivity and irritability due to stress.", "34068-7": "Adult and children 12 years of age and older: dissolve 2 tablets in the mouth 3 times a day.", "34069-5": "60 tablets", "34073-7": "Non habit forming, no drug interactions", "34089-3": "Directions: (adults and children 12 years of age and older): Allow 3 tablets to dissolve in the mouth 3 times a day.", "44425-7": "Store at 68-77 o F (20-25 o C)", "50565-1": "Keep out of reach of children", "50566-9": "Stop use and ask a doctor if symptoms persist continuously for more than 2 weeks or worsen.", "50567-7": "If pregnant or breast-feeding, ask a health professional before use.", "50569-3": "Ask a doctor before use in children younger than 12 years of age.", "51727-6": "Croscarmellose sodium, lactose, magnesium stearate.", "53413-1": "Questions, Comments www.boironusa.com info@boironusa.com 1-800-BOIRON-1 (1-800-264-7661) Boiron Information Center 6 campus Bouelvard Newtown Square, PA 19073-3267", "55105-1": "Aconitum napellus 6C Relieves restlessness, agitation Belladona 6C Relieves hypersensitivity to stress Calendula officinalis 6C Relieves nervous fatigue, hypersensitivity to noise Chelidonium majus 6C Relieves digestive symptoms caused by stress Jequirity 6C Relieves uneasiness Viburnum opulus 6C Relieves nervousness and restless sleep", "55106-9": "Aconitum napellus 6C, Belladona 6C, Calendula officinalis 6C, Chelidonium majus 6C, Jequirity 6C, Viburnum opulus 6C"}