Constipation
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-03-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:04
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Constipation Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
DOSAGE & ADMINISTRATION SECTION
Directions: Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Abies nig. 15x, Aesculus hipp. 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo veg. 15x, Chelidonium majus 15x, Collinsonia 15x, Graphites 15x, Hydrastis 15x, Kali carb. 15x, Lycopodium 15x, Mag. mur. 15x, Mezereum 15x, Nux vom. 15x, Podoph. pelt. 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum alb. 15x, Zinc.met. 15x, Echinacea 3x, Iris versicolor 3x, Phytolacca 3x, Taraxacum 3x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
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.
OTC - 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-1705-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8443-f424-e053-dadaa90a57ce | Constipation |
| 55714-1705-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8443-f424-e053-dadaa90a57ce | Constipation |
| 55714-1705-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8443-f424-e053-dadaa90a57ce | Constipation |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1705-0 | Constipation | 7.08 g in 1 BOTTLE, GLASS | PELLET | 7.08 | 1 | |
| 55714-1705-1 | Constipation | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-1705-2 | Constipation | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-1705 | CONSTIPATION (ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA, GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC. MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 3 package rows | 20131022_94a0263f-ea1d-bd46-4fe8-d02ad0aa062c.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Activated Charcoal | ACTIVE INGREDIENT | 2P3VWU3H10 | 1 | |
| Aloe | ACTIVE INGREDIENT | V5VD430YW9 | 1 | |
| Aluminum Oxide | ACTIVE INGREDIENT | LMI26O6933 | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Chelidonium Majus | ACTIVE INGREDIENT | 7E889U5RNN | 1 | |
| Collinsonia Canadensis Root | ACTIVE INGREDIENT | O2630F3XDR | 1 | |
| Daphne Mezereum Bark | ACTIVE INGREDIENT | X2N6E405GV | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| Frangula Purshiana Bark | ACTIVE INGREDIENT | 4VBP01X99F | 1 | |
| Goldenseal | ACTIVE INGREDIENT | ZW3Z11D0JV | 1 | |
| Graphite | ACTIVE INGREDIENT | 4QQN74LH4O | 1 | |
| Horse Chestnut | ACTIVE INGREDIENT | 3C18L6RJAZ | 1 | |
| Iris Versicolor Root | ACTIVE INGREDIENT | X43D4L3DQC | 1 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 1 | |
| Magnesium Chloride | ACTIVE INGREDIENT | 02F3473H9O | 1 | |
| Phytolacca Americana Root | ACTIVE INGREDIENT | 11E6VI8VEG | 1 | |
| Picea Mariana Resin | ACTIVE INGREDIENT | 71AOV0W131 | 1 | |
| Podophyllum | ACTIVE INGREDIENT | 2S713A4VP3 | 1 | |
| Potassium Carbonate | ACTIVE INGREDIENT | BQN1B9B9HA | 1 | |
| Sanicula Europaea Leaf | ACTIVE INGREDIENT | JYZ6110L9I | 1 | |
| Selenium | ACTIVE INGREDIENT | H6241UJ22B | 1 | |
| Sepia Officinalis Juice | ACTIVE INGREDIENT | QDL83WN8C2 | 1 | |
| Silicon Dioxide | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Taraxacum Officinale | ACTIVE INGREDIENT | 39981FM375 | 1 | |
| Tobacco Leaf | ACTIVE INGREDIENT | 6YR2608RSU | 1 | |
| Veratrum Album Root | ACTIVE INGREDIENT | QNS6W5US1Z | 1 | |
| Zinc | ACTIVE INGREDIENT | J41CSQ7QDS | 1 | |
| Activated Charcoal | ACTIVE MOIETY | 2P3VWU3H10 | 1 | |
| Aloe | ACTIVE MOIETY | V5VD430YW9 | 1 | |
| Aluminum Oxide | ACTIVE MOIETY | LMI26O6933 | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Carbonate Ion | ACTIVE MOIETY | 7UJQ5OPE7D | 1 | |
| Chelidonium Majus | ACTIVE MOIETY | 7E889U5RNN | 1 | |
| Collinsonia Canadensis Root | ACTIVE MOIETY | O2630F3XDR | 1 | |
| Daphne Mezereum Bark | ACTIVE MOIETY | X2N6E405GV | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| Frangula Purshiana Bark | ACTIVE MOIETY | 4VBP01X99F | 1 | |
| Goldenseal | ACTIVE MOIETY | ZW3Z11D0JV | 1 | |
| Graphite | ACTIVE MOIETY | 4QQN74LH4O | 1 | |
| Horse Chestnut | ACTIVE MOIETY | 3C18L6RJAZ | 1 | |
| Iris Versicolor Root | ACTIVE MOIETY | X43D4L3DQC | 1 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 1 | |
| Magnesium Cation | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| Phytolacca Americana Root | ACTIVE MOIETY | 11E6VI8VEG | 1 | |
| Picea Mariana Resin | ACTIVE MOIETY | 71AOV0W131 | 1 | |
| Podophyllum | ACTIVE MOIETY | 2S713A4VP3 | 1 | |
| Sanicula Europaea Leaf | ACTIVE MOIETY | JYZ6110L9I | 1 | |
| Selenium | ACTIVE MOIETY | H6241UJ22B | 1 | |
| Sepia Officinalis Juice | ACTIVE MOIETY | QDL83WN8C2 | 1 | |
| Silicon Dioxide | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Taraxacum Officinale | ACTIVE MOIETY | 39981FM375 | 1 | |
| Tobacco Leaf | ACTIVE MOIETY | 6YR2608RSU | 1 | |
| Veratrum Album Root | ACTIVE MOIETY | QNS6W5US1Z | 1 | |
| Zinc | ACTIVE MOIETY | J41CSQ7QDS | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Constipation
- Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum
- Picea Mariana Resin
- Horse Chestnut
- Aloe
- Aluminum Oxide
- Bryonia Alba Root
- Activated Charcoal
- Chelidonium Majus
- Collinsonia Canadensis Root
- Graphite
- Goldenseal
- Potassium Carbonate
- Carbonate Ion
- Lycopodium Clavatum Spore
- Magnesium Chloride
- Magnesium Cation
- Daphne Mezereum Bark
- Strychnos Nux-vomica Seed
- Podophyllum
- Frangula Purshiana Bark
- Sanicula Europaea Leaf
- Selenium
- Sepia Officinalis Juice
- Silicon Dioxide
- Tobacco Leaf
- Veratrum Album Root
- Zinc
- Echinacea, Unspecified
- Iris Versicolor Root
- Phytolacca Americana Root
- Taraxacum Officinale
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-1705 | 55714-1705-1, 55714-1705-2, 55714-1705-0 |
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, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA |
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 |
|---|---|---|---|---|---|---|
| 95d693a8-616b-557b-ed62-e4f99048c4f4 | 94a0263f-ea1d-bd46-4fe8-d02ad0aa062c | 2011-03-01 | Warnings | 95d693a8-616b-557b-ed62-e4f99048c4f4 94a0263f-ea1d-bd46-4fe8-d02ad0aa062c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
