Unda 312 And 700

Unda 312 And 700
SPL v6
SPL
SPL Set ID 206a5750-2025-205e-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2015-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Berberis Vulgaris Root Bark (4 [hp_X]) Fluoride Ion (12 [hp_X]) Drosera Rotundifolia Flowering Top (6 [hp_X]) Grindelia Hirsutula Flowering Top Pinus Sylvestris Leafy Twig Angelica Archangelica Root Lamium Album Rubus Fruticosus Leaf Polygala Senega Root
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-09-23

Description

Active ingredients Each drop contains: Angelica archangelica (European angelica) Root 6X Drosera (Sundew) Whole Plant 6X Grindelia (Gum-plant) Aerial Parts 6X Lamium album (Dead nettle) Aerial Parts 6X Pinus sylvestris (Scotch pine) Shoots 6X Rubus fruticosus (Shrubby blackberry) Leaf 6X Senega officinalis (Snakeroot) Root 6X


Medication Information

Warnings and Precautions

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache,

nausea and vomiting may be serious.

Consult physician promptly.

Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

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.

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 relief of symptoms associated with sore throat.

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: Angelica archangelica (European angelica) Root 6X Drosera (Sundew) Whole Plant 6X Grindelia (Gum-plant) Aerial Parts 6X Lamium album (Dead nettle) Aerial Parts 6X Pinus sylvestris (Scotch pine) Shoots 6X Rubus fruticosus (Shrubby blackberry) Leaf 6X Senega officinalis (Snakeroot) Root 6X

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 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.

Stop use and ask a doctor if 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 50570-1

Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

Section 51727-6

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4

UNDA

NDC 62106-1169-8

numbered compounds

UNDA 312

Homeopathic Preparation

For the relief of symptoms associated with sore throat.

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 relief of symptoms associated with sore throat.

Section 55106-9

Active ingredients

Each drop contains:

Angelica archangelica (European angelica) Root 6X

Drosera (Sundew) Whole Plant 6X

Grindelia (Gum-plant) Aerial Parts 6X

Lamium album (Dead nettle) Aerial Parts 6X

Pinus sylvestris (Scotch pine) Shoots 6X

Rubus fruticosus (Shrubby blackberry) Leaf 6X

Senega officinalis (Snakeroot) Root 6X

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 relief of symptoms associated with sore throat.

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

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache,

nausea and vomiting may be serious.

Consult physician promptly.

Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

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.

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 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.

Stop use and ask a doctor if 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 50570-1 (50570-1)

Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4 (51945-4)

UNDA

NDC 62106-1169-8

numbered compounds

UNDA 312

Homeopathic Preparation

For the relief of symptoms associated with sore throat.

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 relief of symptoms associated with sore throat.

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Angelica archangelica (European angelica) Root 6X

Drosera (Sundew) Whole Plant 6X

Grindelia (Gum-plant) Aerial Parts 6X

Lamium album (Dead nettle) Aerial Parts 6X

Pinus sylvestris (Scotch pine) Shoots 6X

Rubus fruticosus (Shrubby blackberry) Leaf 6X

Senega officinalis (Snakeroot) Root 6X

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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