Dizziness - Vertigo
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:08
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Dizziness - Vertigo Formulated for symptoms associated with vertigo such as dizziness, disequilibrium, presyncope, nausea and sensations of motion, spinning or floating.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets orally (ages 6 to 11, give 3 pellets) as needed or as directed by a healthcare professional.
ACTIVE INGREDIENT SECTION
Absinthium 20x, Aconitum nap. 20x, Antimon. tart. 20x, Belladonna 20x, Bryonia 20x, Carbolicum acidum 20x, Colchicum 20x, Conium 20x, Ferrum metallicum 20x, Gelsemium 20x, Glonoinum 20x, Hyoscyamus 20x, Ipecac. 20x, Iris versicolor 20x, Lycopodium 20x, Nux vom. 20x, Petroleum 20x, Phosphorus 20x, Sepia 20x, Symphoricarpus racemosus 20x, Tabacum 20x, Theridion 20x, Zingiber 20x, Echinacea 8x, Hypericum 8x, Passiflora 8x, Valeriana 8x, Echinacea 3x, Hypericum 3x, Passiflora 3x, Valeriana 3x.
PURPOSE SECTION
Formulated for symptoms associated with vertigo such as dizziness, disequilibrium, presyncope, nausea and sensations of motion, spinning or floating.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7480e90b-004b-ebe4-2243-4f2fefdd9e78 | Product name | 2 | 20260128 |
| 3f158398-73f2-4b90-47d1-5c60e8719a98 | Product name | 9 | 20250721 |
| ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0 | Product name | 2 | 20250117 |
| 910c1bd7-67d1-44c7-ad4f-9445f827edcc | Product name | 1 | 20230808 |
| 00358076-c817-430b-b924-11d717dc307c | Product name | 1 | 20160718 |
| 669af5aa-14f3-3df7-f100-5f580ffd43c1 | Product name | 1 | 20140508 |
| 6ff3bab7-2dce-8bea-d7ce-54687f0c01fb | Product name | 1 | 20140508 |
| 8bb82a1c-d0d0-fc27-011f-172e545f0382 | Product name | 1 | 20140508 |
| cb03406d-e223-80bb-67d8-be80f9b6a4f2 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4509-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e176-f424-e053-dadaa90a57ce | Dizziness - Vertigo |
| 55714-4509-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e176-f424-e053-dadaa90a57ce | Dizziness - Vertigo |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4509-1 | Dizziness - Vertigo | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-4509-2 | Dizziness - Vertigo | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4509 | DIZZINESS - VERTIGO (ABSINTHIUM, ACONITUM NAP., ANTIMON. TART., BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM, CONIUM, FERRUM METALLICUM, GELSEMIUM, GLONOINUM, HYOSCYAMUS, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, NUX VOM., PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER, ECHINACEA, HYPERICUM, PASSIFLORA, VALERIANA) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20131105_019b93c7-aaa4-b0f8-8ad0-f1bb5f99ad17.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Aconitum Napellus | ACTIVE INGREDIENT | U0NQ8555JD | 1 | |
| Antimony Potassium Tartrate | ACTIVE INGREDIENT | DL6OZ476V3 | 1 | |
| Atropa Belladonna | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Colchicum Autumnale Bulb | ACTIVE INGREDIENT | 993QHL78E6 | 1 | |
| Conium Maculatum Flowering Top | ACTIVE INGREDIENT | Q28R5GF371 | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| Gelsemium Sempervirens Root | ACTIVE INGREDIENT | 639KR60Q1Q | 1 | |
| Ginger | ACTIVE INGREDIENT | C5529G5JPQ | 1 | |
| Hyoscyamus Niger | ACTIVE INGREDIENT | 4WRK2153H3 | 1 | |
| Hypericum Perforatum | ACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| Ipecac | ACTIVE INGREDIENT | 62I3C8233L | 1 | |
| Iris Versicolor Root | ACTIVE INGREDIENT | X43D4L3DQC | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Kerosene | ACTIVE INGREDIENT | 1C89KKC04E | 1 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 1 | |
| Nitroglycerin | ACTIVE INGREDIENT | G59M7S0WS3 | 1 | |
| Passiflora Incarnata Flowering Top | ACTIVE INGREDIENT | CLF5YFS11O | 1 | |
| Phenol | ACTIVE INGREDIENT | 339NCG44TV | 1 | |
| Phosphorus | ACTIVE INGREDIENT | 27YLU75U4W | 1 | |
| Sepia Officinalis Juice | ACTIVE INGREDIENT | QDL83WN8C2 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Symphoricarpos Albus Fruit | ACTIVE INGREDIENT | 873JZU3ASZ | 1 | |
| Theridion Curassavicum | ACTIVE INGREDIENT | 9Z8D3HEM8L | 1 | |
| Tobacco Leaf | ACTIVE INGREDIENT | 6YR2608RSU | 1 | |
| Valerian | ACTIVE INGREDIENT | JWF5YAW3QW | 1 | |
| Wormwood | ACTIVE INGREDIENT | F84709P2XV | 1 | |
| Aconitum Napellus | ACTIVE MOIETY | U0NQ8555JD | 1 | |
| Antimony Cation (3+) | ACTIVE MOIETY | 069647RPT5 | 1 | |
| Atropa Belladonna | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Colchicum Autumnale Bulb | ACTIVE MOIETY | 993QHL78E6 | 1 | |
| Conium Maculatum Flowering Top | ACTIVE MOIETY | Q28R5GF371 | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| Gelsemium Sempervirens Root | ACTIVE MOIETY | 639KR60Q1Q | 1 | |
| Ginger | ACTIVE MOIETY | C5529G5JPQ | 1 | |
| Hyoscyamus Niger | ACTIVE MOIETY | 4WRK2153H3 | 1 | |
| Hypericum Perforatum | ACTIVE MOIETY | XK4IUX8MNB | 1 | |
| Ipecac | ACTIVE MOIETY | 62I3C8233L | 1 | |
| Iris Versicolor Root | ACTIVE MOIETY | X43D4L3DQC | 1 | |
| Iron | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| Kerosene | ACTIVE MOIETY | 1C89KKC04E | 1 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 1 | |
| Nitroglycerin | ACTIVE MOIETY | G59M7S0WS3 | 1 | |
| Passiflora Incarnata Flowering Top | ACTIVE MOIETY | CLF5YFS11O | 1 | |
| Phenol | ACTIVE MOIETY | 339NCG44TV | 1 | |
| Phosphorus | ACTIVE MOIETY | 27YLU75U4W | 1 | |
| Sepia Officinalis Juice | ACTIVE MOIETY | QDL83WN8C2 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Symphoricarpos Albus Fruit | ACTIVE MOIETY | 873JZU3ASZ | 1 | |
| Theridion Curassavicum | ACTIVE MOIETY | 9Z8D3HEM8L | 1 | |
| Tobacco Leaf | ACTIVE MOIETY | 6YR2608RSU | 1 | |
| Valerian | ACTIVE MOIETY | JWF5YAW3QW | 1 | |
| Wormwood | ACTIVE MOIETY | F84709P2XV | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dizziness - Vertigo
- Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana
- Wormwood
- Aconitum Napellus
- Antimony Potassium Tartrate
- Antimony Cation (3+)
- Atropa Belladonna
- Bryonia Alba Root
- Phenol
- Colchicum Autumnale Bulb
- Conium Maculatum Flowering Top
- Iron
- Gelsemium Sempervirens Root
- Nitroglycerin
- Hyoscyamus Niger
- Ipecac
- Iris Versicolor Root
- Lycopodium Clavatum Spore
- Strychnos Nux-vomica Seed
- Kerosene
- Phosphorus
- Sepia Officinalis Juice
- Symphoricarpos Albus Fruit
- Tobacco Leaf
- Theridion Curassavicum
- Ginger
- Echinacea, Unspecified
- Hypericum Perforatum
- Passiflora Incarnata Flowering Top
- Valerian
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4509 | 55714-4509-1, 55714-4509-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 49890bd2-de92-ef17-3c9d-94733802f0ae | 019b93c7-aaa4-b0f8-8ad0-f1bb5f99ad17 | 2011-06-01 | Warnings | 49890bd2-de92-ef17-3c9d-94733802f0ae 019b93c7-aaa4-b0f8-8ad0-f1bb5f99ad17 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
