Unda 240

Unda 240
SPL v3
SPL
SPL Set ID 43a3d9da-f7e9-2257-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2016-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Filipendula Ulmaria Root (6 [hp_X]) Sage Gentiana Lutea Root Saxifraga Granulata Flowering Top Equisetum Arvense Branch
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-12-14

Description

Active ingredients Each drop contains: Equisetum arvense (Common horsetail) Stem 6X Gentiana lutea (Yellow gentian) Underground Parts 6X Salvia officinalis (Garden sage) Leaf 6X Saxifraga granulata Aerial Parts 6X Spiraea ulmaria (Queen-of-themeadow) Underground Parts 6X


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 growing pains.

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: Equisetum arvense (Common horsetail) Stem 6X Gentiana lutea (Yellow gentian) Underground Parts 6X Salvia officinalis (Garden sage) Leaf 6X Saxifraga granulata Aerial Parts 6X Spiraea ulmaria (Queen-of-themeadow) Underground Parts 6X

Section 50565-1

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

Section 51727-6

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4

NDC 62106-1161-8

UNDA

numbered compounds

UNDA 240

Homeopathic Preparation

For the temporary relief of symptoms associated with growing pains.

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 growing pains.

Section 55106-9

Active ingredients

Each drop contains:

Equisetum arvense (Common horsetail) Stem 6X

Gentiana lutea (Yellow gentian) Underground Parts 6X

Salvia officinalis (Garden sage) Leaf 6X

Saxifraga granulata Aerial Parts 6X

Spiraea ulmaria (Queen-of-themeadow) Underground Parts 6X

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 growing pains.

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

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4 (51945-4)

NDC 62106-1161-8

UNDA

numbered compounds

UNDA 240

Homeopathic Preparation

For the temporary relief of symptoms associated with growing pains.

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 growing pains.

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Equisetum arvense (Common horsetail) Stem 6X

Gentiana lutea (Yellow gentian) Underground Parts 6X

Salvia officinalis (Garden sage) Leaf 6X

Saxifraga granulata Aerial Parts 6X

Spiraea ulmaria (Queen-of-themeadow) Underground Parts 6X

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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