Insomnia

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 02:05:01

Label at a glance#

ProductInsomnia

Active ingredientWormwood, Semecarpus Anacardium Juice, Silver Nitrate, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Camphor (natural), Matricaria Recutita, Black Cohosh, Cinchona Officinalis Bark, Arabica Coffee Bean, Cypripedium Parvifolum Root, Gelsemium Sempervirens Root, Hops, Hyoscyamus Niger, Strychnos Ignatii Seed, Potassium Bromide, Strychnos Nux-vomica Seed, Passiflora Incarnata Flowering Top, Pulsatilla Vulgaris, Scutellaria Lateriflora, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig, Valerian

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Insomnia Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat 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

Absinthium 10x, Anacardium orientale 10x, Arg. nit. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Calc. carb. 10x, Camphora 10x, Chamomilla 10x, Cimicifuga 10x, Cinchona 10x, Coffea cruda 10x, Cypripedium 10x, Gelsemium 10x, Humulus 10x, Hyoscyamus 10x, Ignatia 10x, Kali brom.10x, Nux vom. 10x, Passiflora 10x, Pulsatilla 10x, Scutellaria lateriflora 10x, Sepia 10x, Thuja occ. 10x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
6cca4355-1206-91f7-02de-17eef38a8622	Product name	1	20140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-2247-0	2020-01-31	C162847	48780-1	9d75b9cf-ffec-f424-e053-dadaa90a57ce	Insomnia
55714-2247-1	2020-01-31	C162847	48780-1	9d75b9cf-ffec-f424-e053-dadaa90a57ce	Insomnia
55714-2247-2	2020-01-31	C162847	48780-1	9d75b9cf-ffec-f424-e053-dadaa90a57ce	Insomnia

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55714-2247-0	Insomnia	7.08 g in 1 BOTTLE, GLASS	PELLET	7.08	1
55714-2247-1	Insomnia	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35	1
55714-2247-2	Insomnia	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-2247	INSOMNIA (ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 3 package rows	20131015_d4e15024-749a-becb-3c16-dff43a0d9b95.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Arabica Coffee Bean	ACTIVE INGREDIENT	3SW678MX72	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Atropa Belladonna	ACTIVE INGREDIENT	WQZ3G9PF0H	1
Black Cohosh	ACTIVE INGREDIENT	K73E24S6X9	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Camphor (natural)	ACTIVE INGREDIENT	N20HL7Q941	1
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	1
Cypripedium Parvifolum Root	ACTIVE INGREDIENT	21Y9GZ1LZA	1
Gelsemium Sempervirens Root	ACTIVE INGREDIENT	639KR60Q1Q	1
Hops	ACTIVE INGREDIENT	01G73H6H83	1
Hyoscyamus Niger	ACTIVE INGREDIENT	4WRK2153H3	1
Matricaria Recutita	ACTIVE INGREDIENT	G0R4UBI2ZZ	1
Oyster Shell Calcium Carbonate, Crude	ACTIVE INGREDIENT	2E32821G6I	1
Passiflora Incarnata Flowering Top	ACTIVE INGREDIENT	CLF5YFS11O	1
Potassium Bromide	ACTIVE INGREDIENT	OSD78555ZM	1
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	1
Scutellaria Lateriflora	ACTIVE INGREDIENT	7BP4DH5PDC	1
Semecarpus Anacardium Juice	ACTIVE INGREDIENT	Y0F0BU8RDU	1
Sepia Officinalis Juice	ACTIVE INGREDIENT	QDL83WN8C2	1
Silver Nitrate	ACTIVE INGREDIENT	95IT3W8JZE	1
Strychnos Ignatii Seed	ACTIVE INGREDIENT	1NM3M2487K	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Thuja Occidentalis Leafy Twig	ACTIVE INGREDIENT	1NT28V9397	1
Valerian	ACTIVE INGREDIENT	JWF5YAW3QW	1
Wormwood	ACTIVE INGREDIENT	F84709P2XV	1
Arabica Coffee Bean	ACTIVE MOIETY	3SW678MX72	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Atropa Belladonna	ACTIVE MOIETY	WQZ3G9PF0H	1
Black Cohosh	ACTIVE MOIETY	K73E24S6X9	1
Bromide Ion	ACTIVE MOIETY	952902IX06	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Camphor (natural)	ACTIVE MOIETY	N20HL7Q941	1
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	1
Cypripedium Parvifolum Root	ACTIVE MOIETY	21Y9GZ1LZA	1
Gelsemium Sempervirens Root	ACTIVE MOIETY	639KR60Q1Q	1
Hops	ACTIVE MOIETY	01G73H6H83	1
Hyoscyamus Niger	ACTIVE MOIETY	4WRK2153H3	1
Matricaria Recutita	ACTIVE MOIETY	G0R4UBI2ZZ	1
Oyster Shell Calcium Carbonate, Crude	ACTIVE MOIETY	2E32821G6I	1
Passiflora Incarnata Flowering Top	ACTIVE MOIETY	CLF5YFS11O	1
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	1
Scutellaria Lateriflora	ACTIVE MOIETY	7BP4DH5PDC	1
Semecarpus Anacardium Juice	ACTIVE MOIETY	Y0F0BU8RDU	1
Sepia Officinalis Juice	ACTIVE MOIETY	QDL83WN8C2	1
Silver Cation	ACTIVE MOIETY	57N7B0K90A	1
Strychnos Ignatii Seed	ACTIVE MOIETY	1NM3M2487K	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Thuja Occidentalis Leafy Twig	ACTIVE MOIETY	1NT28V9397	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.

DailyMed product names page 1 of 1 · 31 matching rows.

Insomnia
Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana
Wormwood
Semecarpus Anacardium Juice
Silver Nitrate
Silver Cation
Arsenic Trioxide
Arsenic Cation (3+)
Atropa Belladonna
Bryonia Alba Root
Oyster Shell Calcium Carbonate, Crude
Camphor (natural)
Matricaria Recutita
Black Cohosh
Cinchona Officinalis Bark
Arabica Coffee Bean
Cypripedium Parvifolum Root
Gelsemium Sempervirens Root
Hops
Hyoscyamus Niger
Strychnos Ignatii Seed
Potassium Bromide
Bromide Ion
Strychnos Nux-vomica Seed
Passiflora Incarnata Flowering Top
Pulsatilla Vulgaris
Scutellaria Lateriflora
Sepia Officinalis Juice
Thuja Occidentalis Leafy Twig
Valerian
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-2247	55714-2247-1, 55714-2247-2, 55714-2247-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Wormwood	F84709P2XV	ACTIB
Semecarpus Anacardium Juice	Y0F0BU8RDU	ACTIB
Silver Nitrate	95IT3W8JZE	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Atropa Belladonna	WQZ3G9PF0H	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Oyster Shell Calcium Carbonate, Crude	2E32821G6I	ACTIB
Camphor (natural)	N20HL7Q941	ACTIB
Matricaria Recutita	G0R4UBI2ZZ	ACTIB
Black Cohosh	K73E24S6X9	ACTIB
Cinchona Officinalis Bark	S003A158SB	ACTIB
Arabica Coffee Bean	3SW678MX72	ACTIB
Cypripedium Parvifolum Root	21Y9GZ1LZA	ACTIB
Gelsemium Sempervirens Root	639KR60Q1Q	ACTIB
Hops	01G73H6H83	ACTIB
Hyoscyamus Niger	4WRK2153H3	ACTIB
Strychnos Ignatii Seed	1NM3M2487K	ACTIB
Potassium Bromide	OSD78555ZM	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Passiflora Incarnata Flowering Top	CLF5YFS11O	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Scutellaria Lateriflora	7BP4DH5PDC	ACTIB
Sepia Officinalis Juice	QDL83WN8C2	ACTIB
Thuja Occidentalis Leafy Twig	1NT28V9397	ACTIB
Valerian	JWF5YAW3QW	ACTIB
Sucrose	C151H8M554	IACT

Source Document#

Source XML

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ebf5c137-63c5-a23c-cf2d-cd20bac254b1			d4e15024-749a-becb-3c16-dff43a0d9b95	2011-03-01	Warnings	Exact identifier spl id: ebf5c137-63c5-a23c-cf2d-cd20bac254b1 spl set id: d4e15024-749a-becb-3c16-dff43a0d9b95

Reported adverse events (FAERS/openFDA)#

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