UNDA 228- valeriana officinalis root, melissa officinalis whole plant, verbena officinalis whole plant, millefolium whole plant, thymus vulgaris aerial parts, passiflora incarnata aerial parts, lactuca virosa whole plant liquid

Unda 228 by

Drug Labeling and Warnings

Unda 228 by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN’UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PURPOSE

Uses
For the temporary relief of symptoms associated with occasional stress.

WARNINGS

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

ASK DOCTOR

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

INACTIVE INGREDIENT

Inactive Ingredients:

Ethanol (beet),
purified water

OTHER SAFETY INFORMATION

Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.

DOSAGE & 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.

INDICATIONS & 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.

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

UNDA 228 
valeriana officinalis root, melissa officinalis whole plant, verbena officinalis whole plant, millefolium whole plant, thymus vulgaris aerial parts, passiflora incarnata aerial parts, lactuca virosa whole plant liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-1159
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	4 [hp_X]  in 20 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	4 [hp_X]  in 20 mL
LACTUCA VIROSA (UNII: 6D74QW4H67) (LACTUCA VIROSA - UNII:6D74QW4H67)	LACTUCA VIROSA	4 [hp_X]  in 20 mL
THYME (UNII: CW657OBU4N) (THYME - UNII:CW657OBU4N)	THYME	4 [hp_X]  in 20 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	4 [hp_X]  in 20 mL
VERBENA OFFICINALIS (UNII: QT8A71T9BM) (VERBENA OFFICINALIS - UNII:QT8A71T9BM)	VERBENA OFFICINALIS	4 [hp_X]  in 20 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	4 [hp_X]  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-1159-8	1 in 1 BOX	12/17/2014
1		20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/17/2014

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN’UP		401010287	manufacture(62106-1159)