FDA.reportPublic FDA data

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 02:04:55

Label at a glance#

ProductConstipation
Active ingredientPicea Mariana Resin, Horse Chestnut, Aloe, Aluminum Oxide, Bryonia Alba Root, Activated Charcoal, Chelidonium Majus, Collinsonia Canadensis Root, Graphite, Goldenseal, Potassium Carbonate, Lycopodium Clavatum Spore, Magnesium Chloride, 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
Label structure10 sections

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: ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop 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: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-1505-02020-01-31C16284748780-19d75b9d0-3e5f-f424-e053-dadaa90a57ceConstipation
55714-1505-12020-01-31C16284748780-19d75b9d0-3e5f-f424-e053-dadaa90a57ceConstipation
55714-1505-22020-01-31C16284748780-19d75b9d0-3e5f-f424-e053-dadaa90a57ceConstipation

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1505-0Constipation.5 mL in 1 BOTTLE, GLASSLIQUID.51
55714-1505-1Constipation29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-1505-2Constipation59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1505CONSTIPATION (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) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 3 package rows20130827_c432f634-7f4d-78fe-4906-df3520dae204.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Activated CharcoalACTIVE INGREDIENT2P3VWU3H101
AloeACTIVE INGREDIENTV5VD430YW91
Aluminum OxideACTIVE INGREDIENTLMI26O69331
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Collinsonia Canadensis RootACTIVE INGREDIENTO2630F3XDR1
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Frangula Purshiana BarkACTIVE INGREDIENT4VBP01X99F1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
GraphiteACTIVE INGREDIENT4QQN74LH4O1
Horse ChestnutACTIVE INGREDIENT3C18L6RJAZ1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Magnesium ChlorideACTIVE INGREDIENT02F3473H9O1
Phytolacca Americana RootACTIVE INGREDIENT11E6VI8VEG1
Picea Mariana ResinACTIVE INGREDIENT71AOV0W1311
PodophyllumACTIVE INGREDIENT2S713A4VP31
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA1
Sanicula Europaea LeafACTIVE INGREDIENTJYZ6110L9I1
SeleniumACTIVE INGREDIENTH6241UJ22B1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU41
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3751
Tobacco LeafACTIVE INGREDIENT6YR2608RSU1
Veratrum Album RootACTIVE INGREDIENTQNS6W5US1Z1
ZincACTIVE INGREDIENTJ41CSQ7QDS1
Activated CharcoalACTIVE MOIETY2P3VWU3H101
AloeACTIVE MOIETYV5VD430YW91
Aluminum OxideACTIVE MOIETYLMI26O69331
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Collinsonia Canadensis RootACTIVE MOIETYO2630F3XDR1
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Frangula Purshiana BarkACTIVE MOIETY4VBP01X99F1
GoldensealACTIVE MOIETYZW3Z11D0JV1
GraphiteACTIVE MOIETY4QQN74LH4O1
Horse ChestnutACTIVE MOIETY3C18L6RJAZ1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Magnesium CationACTIVE MOIETYT6V3LHY8381
Phytolacca Americana RootACTIVE MOIETY11E6VI8VEG1
Picea Mariana ResinACTIVE MOIETY71AOV0W1311
PodophyllumACTIVE MOIETY2S713A4VP31
Sanicula Europaea LeafACTIVE MOIETYJYZ6110L9I1
SeleniumACTIVE MOIETYH6241UJ22B1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
Silicon DioxideACTIVE MOIETYETJ7Z6XBU41
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Taraxacum OfficinaleACTIVE MOIETY39981FM3751
Tobacco LeafACTIVE MOIETY6YR2608RSU1
Veratrum Album RootACTIVE MOIETYQNS6W5US1Z1
ZincACTIVE MOIETYJ41CSQ7QDS1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-150555714-1505-1, 55714-1505-2, 55714-1505-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
Picea Mariana Resin71AOV0W131ACTIB
Horse Chestnut3C18L6RJAZACTIB
AloeV5VD430YW9ACTIB
Aluminum OxideLMI26O6933ACTIB
Bryonia Alba RootT7J046YI2BACTIB
Activated Charcoal2P3VWU3H10ACTIB
Chelidonium Majus7E889U5RNNACTIB
Collinsonia Canadensis RootO2630F3XDRACTIB
Graphite4QQN74LH4OACTIB
GoldensealZW3Z11D0JVACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Magnesium Chloride02F3473H9OACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Podophyllum2S713A4VP3ACTIB
Frangula Purshiana Bark4VBP01X99FACTIB
Sanicula Europaea LeafJYZ6110L9IACTIB
SeleniumH6241UJ22BACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Tobacco Leaf6YR2608RSUACTIB
Veratrum Album RootQNS6W5US1ZACTIB
ZincJ41CSQ7QDSACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Phytolacca Americana Root11E6VI8VEGACTIB
Taraxacum Officinale39981FM375ACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML · Source PDF

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.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
577e4bf2-48a3-16fc-e6dc-33d80a5aecb6c432f634-7f4d-78fe-4906-df3520dae2042011-03-01WarningsExact identifier
spl id: 577e4bf2-48a3-16fc-e6dc-33d80a5aecb6
spl set id: c432f634-7f4d-78fe-4906-df3520dae204

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.