Unda 19

Unda 19
SPL v4
SPL
SPL Set ID 4c47f5cd-fcb3-3ecb-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2018-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum (12 [hp_X]) Star Anise Fruit (3 [hp_X]) Polygala Senega Root (4 [hp_X]) Drosera Rotundifolia Flowering Top (5 [hp_X]) Peppermint
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-04-03

Description

Active ingredients Each drop contains: Aluminium metallicum (Aluminum) 12X Drosera (Sundew) Whole Plant 5X Illicium verum (Star anise) Fruit 3X Mentha piperita Aerial Parts 5X Senega officinalis (Seneca snakeroot) Root 4X


Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have

Persistent or chronic cough such as

occurs with smoking, asthma, chronic

bronchitis, or emphysema.

Cough that is accompanied by

excessive phlegm (mucus) or fever.

Stop use and ask a doctor if

Cough persists for more than 1 week,

tends to recur, or is accompanied by a

fever, rash, or persistent headache. A

persistent cough may be a sign of a

serious condition.

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 minor respiratory problems.

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: Aluminium metallicum (Aluminum) 12X Drosera (Sundew) Whole Plant 5X Illicium verum (Star anise) Fruit 3X Mentha piperita Aerial Parts 5X Senega officinalis (Seneca snakeroot) Root 4X

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 50566-9

Stop use and ask a doctor if

Cough persists for more than 1 week,

tends to recur, or is accompanied by a

fever, rash, or persistent headache. A

persistent cough may be a sign of a

serious condition.

Symptoms persist or worsen.

Section 50569-3

Ask a doctor before use if you have

Persistent or chronic cough such as

occurs with smoking, asthma, chronic

bronchitis, or emphysema.

Cough that is accompanied by

excessive phlegm (mucus) or fever

Section 51727-6

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4

NDC 62106-1118-8

UNDA

numbered compounds

UNDA 19

Homeopathic Preparation

For the temporary relief of symptoms

associated with minor respiratory problems.

Contains 32% 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 minor respiratory problems.

Section 55106-9

Active ingredients

Each drop contains:

Aluminium metallicum (Aluminum) 12X

Drosera (Sundew) Whole Plant 5X

Illicium verum (Star anise) Fruit 3X

Mentha piperita Aerial Parts 5X

Senega officinalis (Seneca snakeroot) Root 4X

Section 60561-8

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.

Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of symptoms associated with minor respiratory problems.

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

Ask a doctor before use if you have

Persistent or chronic cough such as

occurs with smoking, asthma, chronic

bronchitis, or emphysema.

Cough that is accompanied by

excessive phlegm (mucus) or fever.

Stop use and ask a doctor if

Cough persists for more than 1 week,

tends to recur, or is accompanied by a

fever, rash, or persistent headache. A

persistent cough may be a sign of a

serious condition.

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 50566-9 (50566-9)

Stop use and ask a doctor if

Cough persists for more than 1 week,

tends to recur, or is accompanied by a

fever, rash, or persistent headache. A

persistent cough may be a sign of a

serious condition.

Symptoms persist or worsen.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

Persistent or chronic cough such as

occurs with smoking, asthma, chronic

bronchitis, or emphysema.

Cough that is accompanied by

excessive phlegm (mucus) or fever

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4 (51945-4)

NDC 62106-1118-8

UNDA

numbered compounds

UNDA 19

Homeopathic Preparation

For the temporary relief of symptoms

associated with minor respiratory problems.

Contains 32% 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 minor respiratory problems.

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Aluminium metallicum (Aluminum) 12X

Drosera (Sundew) Whole Plant 5X

Illicium verum (Star anise) Fruit 3X

Mentha piperita Aerial Parts 5X

Senega officinalis (Seneca snakeroot) Root 4X

Section 60561-8 (60561-8)

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.

Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity


Advanced Ingredient Data


Raw Label Data

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