UNDA 312, UNDA 700
Generic: ANGELICA ARCHANGELICA, DROSERA, GRINDELIA, LAMIUM ALBUM, PINUS SYLVESTRIS, RUBUS FRUTICOSUS, SENEGA OFFICINALIS, BERBERIS VULGARIS, CALCAREA FLUORICA
Basic Information
Manufacturer
Seroyal USA
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
206a5750-2025-205e-e054-00144ff8d46c
Purpose
Uses For the relief of symptoms associated with sore throat.
Uses For the relief of symptoms associated with low energy and fatigue
Uses For the relief of symptoms associated with low energy and fatigue
Indications & 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.
Uses For the relief of symptoms associated with low energy and fatigue 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.
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.
Uses For the relief of symptoms associated with low energy and fatigue 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
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.
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.
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.
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.
Technical Data
{
"spl_product_data_elements": [
"UNDA 700 Berberis vulgaris, Calcarea fluorica BERBERIS VULGARIS ROOT BARK BERBERIS VULGARIS ROOT BARK CALCIUM FLUORIDE FLUORIDE ION ALCOHOL WATER UNDA 312 Angelica archangelica, Drosera, Grindelia, Lamium album, Pinus sylvestris, Rubus fruticosus, Senega officinalis DROSERA ROTUNDIFOLIA FLOWERING TOP DROSERA ROTUNDIFOLIA FLOWERING TOP GRINDELIA HIRSUTULA FLOWERING TOP GRINDELIA HIRSUTULA FLOWERING TOP PINUS SYLVESTRIS LEAFY TWIG PINUS SYLVESTRIS LEAFY TWIG ALCOHOL WATER ANGELICA ARCHANGELICA ROOT ANGELICA ARCHANGELICA ROOT LAMIUM ALBUM LAMIUM ALBUM RUBUS FRUTICOSUS LEAF RUBUS FRUTICOSUS LEAF POLYGALA SENEGA ROOT POLYGALA SENEGA ROOT"
],
"active_ingredient": [
"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",
"Active ingredients Each drop contains equal parts of: Berberis vulgaris (Barberry) Bark 4X Calcarea fluorica (Calcium fluoride) 12X"
],
"purpose": [
"Uses For the relief of symptoms associated with sore throat.",
"Uses For the relief of symptoms associated with low energy and fatigue"
],
"warnings": [
"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.",
"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."
],
"ask_doctor": [
"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": [
"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.",
"Stop use and ask a doctor if symptoms persist or worsen."
],
"do_not_use": [
"Do not use more than 2 days or administer to children under 3 years of age unless directed by physician."
],
"pregnancy_or_breast_feeding": [
"If pregnant or breastfeeding, ask a health professional before use.",
"If pregnant or breastfeeding, ask a health professional before use."
],
"keep_out_of_reach_of_children": [
"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.",
"In case of overdose, get medical help or contact a Poison Control Center right away."
],
"inactive_ingredient": [
"Inactive ingredients Ethanol (beet), purified water",
"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. Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.",
"Other information Do not use if seal is missing or broken. Store in a cool, dry place."
],
"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.",
"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_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.",
"Uses For the relief of symptoms associated with low energy and fatigue 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."
],
"package_label_principal_display_panel": [
"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) 62106-1169",
"UNDA NDC 62106-1171-8 numbered compounds UNDA 700 Homeopathic Preparation Contains 31% Alcohol 0.7 fl oz (20 mL) NDC"
],
"set_id": "206a5750-2025-205e-e054-00144ff8d46c",
"id": "c733ec78-5b43-7a7c-e053-2995a90a2f9a",
"effective_time": "20210715",
"version": "6",
"openfda": {
"brand_name": [
"UNDA 312",
"UNDA 700"
],
"generic_name": [
"ANGELICA ARCHANGELICA, DROSERA, GRINDELIA, LAMIUM ALBUM, PINUS SYLVESTRIS, RUBUS FRUTICOSUS, SENEGA OFFICINALIS",
"BERBERIS VULGARIS, CALCAREA FLUORICA"
],
"manufacturer_name": [
"Seroyal USA"
],
"product_ndc": [
"62106-1169",
"62106-1171"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"ANGELICA ARCHANGELICA ROOT",
"DROSERA ROTUNDIFOLIA FLOWERING TOP",
"GRINDELIA HIRSUTULA FLOWERING TOP",
"LAMIUM ALBUM",
"PINUS SYLVESTRIS LEAFY TWIG",
"POLYGALA SENEGA ROOT",
"RUBUS FRUTICOSUS LEAF",
"BERBERIS VULGARIS ROOT BARK",
"CALCIUM FLUORIDE"
],
"spl_id": [
"c733ec78-5b43-7a7c-e053-2995a90a2f9a"
],
"spl_set_id": [
"206a5750-2025-205e-e054-00144ff8d46c"
],
"package_ndc": [
"62106-1171-8",
"62106-1169-8"
],
"is_original_packager": [
true
],
"upc": [
"0883196304608"
],
"unii": [
"046Y1357I6",
"YQ2S06L8S9",
"1TH8Q20J0U",
"DTN01M69SN",
"M7T6H7D4IF",
"O3B55K4YKI",
"IDB0NAZ6AI",
"Q1RGP4UB73",
"75O014T1HG"
]
}
}