Unda 228

Unda 228
SPL v6
SPL
SPL Set ID 0a6f8408-bdbc-09c6-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2017-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Melissa Officinalis (4 [hp_X]) Achillea Millefolium Lactuca Virosa Thyme Passiflora Incarnata Flowering Top Verbena Officinalis Valerian
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-12-17

Description

Active ingredients Each drop contains: Lactuca virosa (Poisonous lettuce) Whole Plant 4X Melissa officinalis (Lemon balm) Leaf/Young Shoot 4X Millefolium (Yarrow) Aerial Parts 4X Passiflora incarnata (Passion flower) Aerial Parts 4X Thymus vulgaris Aerial Parts 4X Valeriana officinalis (Valerian) Root 4X Verbena officinalis (Common vervain) Aerial Parts 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

For the temporary relief of symptoms associated with occasional stress.

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: Lactuca virosa (Poisonous lettuce) Whole Plant 4X Melissa officinalis (Lemon balm) Leaf/Young Shoot 4X Millefolium (Yarrow) Aerial Parts 4X Passiflora incarnata (Passion flower) Aerial Parts 4X Thymus vulgaris Aerial Parts 4X Valeriana officinalis (Valerian) Root 4X Verbena officinalis (Common vervain) Aerial Parts 4X.

Section 34088-5

In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 50565-1

Keep out of reach of children.

Section 50569-3

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

Section 51727-6

Inactive Ingredients:

Ethanol (beet),

purified water

Section 51945-4

NDC 62106-1159-8

UNDA

numbered compounds

UNDA 228

Homeopathic Preparation

For the temporary relief

of symptomsassociated with

occasional stress.

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

For the temporary relief of symptoms associated with occasional stress.

Section 55106-9

Active ingredients

Each drop contains:

Lactuca virosa (Poisonous lettuce) Whole Plant 4X

Melissa officinalis (Lemon balm) Leaf/Young Shoot 4X

Millefolium (Yarrow) Aerial Parts 4X

Passiflora incarnata (Passion flower) Aerial Parts 4X

Thymus vulgaris Aerial Parts 4X

Valeriana officinalis (Valerian) Root 4X

Verbena officinalis (Common vervain) Aerial Parts 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

For the temporary relief of symptoms associated with occasional stress.

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 34088-5 (34088-5)

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 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

Inactive Ingredients:

Ethanol (beet),

purified water

Section 51945-4 (51945-4)

NDC 62106-1159-8

UNDA

numbered compounds

UNDA 228

Homeopathic Preparation

For the temporary relief

of symptomsassociated with

occasional stress.

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

For the temporary relief of symptoms associated with occasional stress.

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Lactuca virosa (Poisonous lettuce) Whole Plant 4X

Melissa officinalis (Lemon balm) Leaf/Young Shoot 4X

Millefolium (Yarrow) Aerial Parts 4X

Passiflora incarnata (Passion flower) Aerial Parts 4X

Thymus vulgaris Aerial Parts 4X

Valeriana officinalis (Valerian) Root 4X

Verbena officinalis (Common vervain) Aerial Parts 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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