Hemorrhoids
- 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 02:05:06
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
HEMORRHOIDS Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pelles in purified water.
ACTIVE INGREDIENT SECTION
Elaps corallinus 35x, Aesculus hipp. 20x, Aloe 20x, Arsenicum alb. 20x, Bryonia 20x, Calc. fluor. 20x, Capsicum 20x, Collinsonia 20x, Crotalus horridus 20x, Hamamelis 20x, Hydrofluoricum acidum 20x, Hypericum 20x, Lachesis 20x, Lycopodium 20x, Millefolium 20x, Naja 20x, Nux vom. 20x, Paeonia 20x, Plantago 20x, Quercus glandium spiritus 20x, Ratanhia 20x, Vipera berus 20x, Aesculus hipp 8x, Echinacea 8x, Solidago 8x, Urtica ur. 8x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.
PURPOSE SECTION
Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.
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 or 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 |
|---|---|---|---|
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4447-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0016-f424-e053-dadaa90a57ce | Hemorrhoids |
| 55714-4447-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0016-f424-e053-dadaa90a57ce | Hemorrhoids |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4447-1 | Hemorrhoids | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-4447-2 | Hemorrhoids | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4447 | HEMORRHOIDS (ELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20131030_7dc634ae-f77e-d29e-8d50-4ebce37dbc99.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Achillea Millefolium | ACTIVE INGREDIENT | 2FXJ6SW4PK | 1 | |
| Aloe | ACTIVE INGREDIENT | V5VD430YW9 | 1 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Calcium Fluoride | ACTIVE INGREDIENT | O3B55K4YKI | 1 | |
| Capsicum | ACTIVE INGREDIENT | 00UK7646FG | 1 | |
| Collinsonia Canadensis Root | ACTIVE INGREDIENT | O2630F3XDR | 1 | |
| Crotalus Horridus Horridus Venom | ACTIVE INGREDIENT | YHA2XLJ956 | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| Hamamelis Virginiana Root Bark/stem Bark | ACTIVE INGREDIENT | T7S323PKJS | 1 | |
| Horse Chestnut | ACTIVE INGREDIENT | 3C18L6RJAZ | 1 | |
| Hydrofluoric Acid | ACTIVE INGREDIENT | RGL5YE86CZ | 1 | |
| Hypericum Perforatum | ACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| Krameria Lappacea Root | ACTIVE INGREDIENT | P29ZH1A35Z | 1 | |
| Lachesis Muta Venom | ACTIVE INGREDIENT | VSW71SS07I | 1 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 1 | |
| Micrurus Corallinus Venom | ACTIVE INGREDIENT | V0S6H36980 | 1 | |
| Naja Naja Venom | ACTIVE INGREDIENT | ZZ4AG7L7VM | 1 | |
| Paeonia Officinalis Root | ACTIVE INGREDIENT | 8R564U2E1P | 1 | |
| Plantago Major | ACTIVE INGREDIENT | W2469WNO6U | 1 | |
| Quercus Robur Nut | ACTIVE INGREDIENT | Q7MU1F4GLY | 1 | |
| Solidago Virgaurea Flowering Top | ACTIVE INGREDIENT | 5405K23S50 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Urtica Urens | ACTIVE INGREDIENT | IHN2NQ5OF9 | 1 | |
| Vipera Berus Venom | ACTIVE INGREDIENT | 0ORO6NCA4M | 1 | |
| Achillea Millefolium | ACTIVE MOIETY | 2FXJ6SW4PK | 1 | |
| Aloe | ACTIVE MOIETY | V5VD430YW9 | 1 | |
| Arsenic Cation (3+) | ACTIVE MOIETY | C96613F5AV | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Capsicum | ACTIVE MOIETY | 00UK7646FG | 1 | |
| Collinsonia Canadensis Root | ACTIVE MOIETY | O2630F3XDR | 1 | |
| Crotalus Horridus Horridus Venom | ACTIVE MOIETY | YHA2XLJ956 | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| Fluoride Ion | ACTIVE MOIETY | Q80VPU408O | 1 | |
| Hamamelis Virginiana Root Bark/stem Bark | ACTIVE MOIETY | T7S323PKJS | 1 | |
| Horse Chestnut | ACTIVE MOIETY | 3C18L6RJAZ | 1 | |
| Hypericum Perforatum | ACTIVE MOIETY | XK4IUX8MNB | 1 | |
| Krameria Lappacea Root | ACTIVE MOIETY | P29ZH1A35Z | 1 | |
| Lachesis Muta Venom | ACTIVE MOIETY | VSW71SS07I | 1 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 1 | |
| Micrurus Corallinus Venom | ACTIVE MOIETY | V0S6H36980 | 1 | |
| Naja Naja Venom | ACTIVE MOIETY | ZZ4AG7L7VM | 1 | |
| Paeonia Officinalis Root | ACTIVE MOIETY | 8R564U2E1P | 1 | |
| Plantago Major | ACTIVE MOIETY | W2469WNO6U | 1 | |
| Quercus Robur Nut | ACTIVE MOIETY | Q7MU1F4GLY | 1 | |
| Solidago Virgaurea Flowering Top | ACTIVE MOIETY | 5405K23S50 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Urtica Urens | ACTIVE MOIETY | IHN2NQ5OF9 | 1 | |
| Vipera Berus Venom | ACTIVE MOIETY | 0ORO6NCA4M | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Hemorrhoids
- Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Echinacea, Solidago, Urtica ur.
- Micrurus Corallinus Venom
- Horse Chestnut
- Aloe
- Arsenic Trioxide
- Arsenic Cation (3+)
- Bryonia Alba Root
- Calcium Fluoride
- Fluoride Ion
- Capsicum
- Collinsonia Canadensis Root
- Crotalus Horridus Horridus Venom
- Hamamelis Virginiana Root Bark/stem Bark
- Hydrofluoric Acid
- Hypericum Perforatum
- Lachesis Muta Venom
- Lycopodium Clavatum Spore
- Achillea Millefolium
- Naja Naja Venom
- Strychnos Nux-vomica Seed
- Paeonia Officinalis Root
- Plantago Major
- Quercus Robur Nut
- Krameria Lappacea Root
- Vipera Berus Venom
- Echinacea, Unspecified
- Solidago Virgaurea Flowering Top
- Urtica Urens
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4447 | 55714-4447-1, 55714-4447-2 |
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 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 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 |
|---|---|---|---|---|---|---|
| 5f9dab33-834a-6417-a20b-2fa3be13e1d2 | 7dc634ae-f77e-d29e-8d50-4ebce37dbc99 | 2011-06-01 | Warnings | 5f9dab33-834a-6417-a20b-2fa3be13e1d2 7dc634ae-f77e-d29e-8d50-4ebce37dbc99 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
