Unda 219

Unda 219
SPL v4
SPL
SPL Set ID 2f0cd4d0-55ab-64b4-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2016-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lactuca Virosa (4 [hp_X]) Crataegus Fruit Thyme Passiflora Incarnata Flowering Top Valerian
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-03-27

Description

Active ingredients Each drop contains: Crataegus (Hawthorn) Fruit 4X Lactuca virosa (Poisonous lettuce) Whole Plant 4X Passiflora incarnata (Passion flower) Aerial Parts 4X Thymus vulgaris Aerial Parts 4X Valeriana officinalis (Valerian) Root 4X


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage

Uses

Helps to promote relaxation and temporarily relieve mild nervousness

Directions

Adults and adolescents (12 years and older): Take 5 drops three times daily or as

recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your

healthcare practitioner.

Dosage and Administration

Directions

Adults and adolescents (12 years and older)

Take 5 drops three times daily or as recommended by your healthcare practitioner.

Children (under 12 years)

Take under the direction of your healthcare practitioner

Description

Active ingredients Each drop contains: Crataegus (Hawthorn) Fruit 4X Lactuca virosa (Poisonous lettuce) Whole Plant 4X Passiflora incarnata (Passion flower) Aerial Parts 4X Thymus vulgaris Aerial Parts 4X Valeriana officinalis (Valerian) Root 4X

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4

NDC 62106-1156-8

UNDA

numbered compounds

UNDA 219

Homeopathic Preparation

Helps to promote relaxation and temporarily relieve mild nervousness.

Contains 31% Alcohol

0.7 fl oz (20 ml)

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Uses

Helps to promote relaxation and temporarily relieve mild nervousness

Section 55106-9

Active ingredients

Each drop contains:

Crataegus (Hawthorn) Fruit 4X

Lactuca virosa (Poisonous lettuce) Whole Plant 4X

Passiflora incarnata (Passion flower) Aerial Parts 4X

Thymus vulgaris Aerial Parts 4X

Valeriana officinalis (Valerian) Root 4X

Section 60561-8

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps to promote relaxation and temporarily relieve mild nervousness

Directions

Adults and adolescents (12 years and older): Take 5 drops three times daily or as

recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your

healthcare practitioner.

Dosage and Administration (34068-7)

Directions

Adults and adolescents (12 years and older)

Take 5 drops three times daily or as recommended by your healthcare practitioner.

Children (under 12 years)

Take under the direction of your healthcare practitioner

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4 (51945-4)

NDC 62106-1156-8

UNDA

numbered compounds

UNDA 219

Homeopathic Preparation

Helps to promote relaxation and temporarily relieve mild nervousness.

Contains 31% Alcohol

0.7 fl oz (20 ml)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

Helps to promote relaxation and temporarily relieve mild nervousness

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Crataegus (Hawthorn) Fruit 4X

Lactuca virosa (Poisonous lettuce) Whole Plant 4X

Passiflora incarnata (Passion flower) Aerial Parts 4X

Thymus vulgaris Aerial Parts 4X

Valeriana officinalis (Valerian) Root 4X

Section 60561-8 (60561-8)

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.


Advanced Ingredient Data


Raw Label Data

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