Cold - Cough

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:05:06

Label at a glance#

ProductCold - Cough

Active ingredientInfluenza A Virus, American Ginseng, Arsenic Trioxide, Bryonia Alba Root, Euphrasia Stricta, Gaultheria Procumbens Top, Gelsemium Sempervirens Root, Calcium Sulfide, Histamine Dihydrochloride, Goldenseal, Potassium Dichromate, Mercury, Phosphorus, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Schoenocaulon Officinale Seed, Sage, Lobaria Pulmonaria, Verbascum Thapsus, Echinacea, Unspecified, Influenza B Virus

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

Cold Cough Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

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 pellets in purified water.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Influenzinum 35x, Aralia quinquefolia 20x, Arsenicum alb. 20x, Bryonia 20x, Euphrasia 20x, Gaultheria procumbens 20x, Gelsemium 20x, Hepar sulph. calc. 20x, Histaminum hydrochloricum 20x, Hydrastis 20x, Kali bic. 20x, Merc. viv. 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sabadilla 20x, Salvia 20x, Sticta 20x, Verbascum 20x, Echinacea 8x, Hydrastis 8x, Echinacea 3x, Hydrastis 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

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.

PREGNANCY OR BREAST FEEDING SECTION

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.

KEEP OUT OF REACH OF CHILDREN SECTION

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4421-1	2020-01-31	C162847	48780-1	9d75b9d0-006a-f424-e053-dadaa90a57ce	Cold - Cough
55714-4421-2	2020-01-31	C162847	48780-1	9d75b9d0-006a-f424-e053-dadaa90a57ce	Cold - Cough

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4421-1	Cold - Cough	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		2
55714-4421-2	Cold - Cough	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4421	COLD - COUGH (INFLUENZINUM, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUMBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA) PELLET [NEWTON LABORATORIES, INC.]	2	Legacy NDC, 2 package rows	20131025_b88544ce-50b9-33d9-9cdf-e08f6e012fec.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
American Ginseng	ACTIVE INGREDIENT	8W75VCV53Q	2
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	2
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	2
Calcium Sulfide	ACTIVE INGREDIENT	1MBW07J51Q	2
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	2
Euphrasia Stricta	ACTIVE INGREDIENT	C9642I91WL	2
Gaultheria Procumbens Top	ACTIVE INGREDIENT	830295X963	2
Gelsemium Sempervirens Root	ACTIVE INGREDIENT	639KR60Q1Q	2
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	2
Histamine Dihydrochloride	ACTIVE INGREDIENT	3POA0Q644U	2
Influenza A Virus	ACTIVE INGREDIENT	R9HH0NDE2E	2
Influenza B Virus	ACTIVE INGREDIENT	1314JZ2X6W	2
Lobaria Pulmonaria	ACTIVE INGREDIENT	D1YM0P5Z2T	2
Mercury	ACTIVE INGREDIENT	FXS1BY2PGL	2
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	2
Potassium Dichromate	ACTIVE INGREDIENT	T4423S18FM	2
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	2
Sage	ACTIVE INGREDIENT	065C5D077J	2
Schoenocaulon Officinale Seed	ACTIVE INGREDIENT	6NAF1689IO	2
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	2
Verbascum Thapsus	ACTIVE INGREDIENT	C9TD27U172	2
American Ginseng	ACTIVE MOIETY	8W75VCV53Q	2
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	2
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	2
Calcium Sulfide	ACTIVE MOIETY	1MBW07J51Q	2
Dichromate Ion	ACTIVE MOIETY	9LKY4BFN2V	2
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	2
Euphrasia Stricta	ACTIVE MOIETY	C9642I91WL	2
Gaultheria Procumbens Top	ACTIVE MOIETY	830295X963	2
Gelsemium Sempervirens Root	ACTIVE MOIETY	639KR60Q1Q	2
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	2
Histamine	ACTIVE MOIETY	820484N8I3	2
Influenza A Virus	ACTIVE MOIETY	R9HH0NDE2E	2
Influenza B Virus	ACTIVE MOIETY	1314JZ2X6W	2
Lobaria Pulmonaria	ACTIVE MOIETY	D1YM0P5Z2T	2
Mercury	ACTIVE MOIETY	FXS1BY2PGL	2
Phosphorus	ACTIVE MOIETY	27YLU75U4W	2
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	2
Sage	ACTIVE MOIETY	065C5D077J	2
Schoenocaulon Officinale Seed	ACTIVE MOIETY	6NAF1689IO	2
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	2
Verbascum Thapsus	ACTIVE MOIETY	C9TD27U172	2
Sucrose	INACTIVE INGREDIENT	C151H8M554	2

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

Cold - Cough
Influenzinum, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea
Influenza A Virus
American Ginseng
Arsenic Trioxide
Arsenic Cation (3+)
Bryonia Alba Root
Euphrasia Stricta
Gaultheria Procumbens Top
Gelsemium Sempervirens Root
Calcium Sulfide
Histamine Dihydrochloride
Histamine
Goldenseal
Potassium Dichromate
Dichromate Ion
Mercury
Phosphorus
Pulsatilla Vulgaris
Toxicodendron Pubescens Leaf
Schoenocaulon Officinale Seed
Sage
Lobaria Pulmonaria
Verbascum Thapsus
Echinacea, Unspecified
Sucrose
Influenza B Virus

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4421	55714-4421-1, 55714-4421-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Influenza A Virus	R9HH0NDE2E	ACTIB
American Ginseng	8W75VCV53Q	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Euphrasia Stricta	C9642I91WL	ACTIB
Gaultheria Procumbens Top	830295X963	ACTIB
Gelsemium Sempervirens Root	639KR60Q1Q	ACTIB
Calcium Sulfide	1MBW07J51Q	ACTIB
Histamine Dihydrochloride	3POA0Q644U	ACTIB
Goldenseal	ZW3Z11D0JV	ACTIB
Potassium Dichromate	T4423S18FM	ACTIB
Mercury	FXS1BY2PGL	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Schoenocaulon Officinale Seed	6NAF1689IO	ACTIB
Sage	065C5D077J	ACTIB
Lobaria Pulmonaria	D1YM0P5Z2T	ACTIB
Verbascum Thapsus	C9TD27U172	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Sucrose	C151H8M554	IACT
Influenza B Virus	1314JZ2X6W	ACTIB

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	LOZENGE / BUCCAL	NA		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 / INTRAVENOUS		1950 mg	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	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 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	SUSPENSION, EXTENDED RELEASE / ORAL		5400 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	LOZENGE / TRANSMUCOSAL		1255 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	TABLET, CHEWABLE / ORAL		7258 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	CAPSULE, EXTENDED RELEASE / ORAL		619 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	INJECTION, EMULSION / INTRAVENOUS		970 mg	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	SOLUTION / RECTAL	35.42 %w/v		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	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 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	PASTILLE / ORAL	426 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	POWDER / ORAL		27768 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	GRANULE, FOR SOLUTION / ORAL		42596 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	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 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	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 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	SUPPOSITORY / RECTAL	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 / ORAL		3568 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	TABLET / SUBLINGUAL	109 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 / ORAL		4249 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	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		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	SOLUTION / ORAL		70000 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	INJECTION, SOLUTION / INTRAVENOUS	NA		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	TABLET, EXTENDED RELEASE / ORAL	284.54 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, DELAYED RELEASE / ORAL		955 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

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
b6445d2c-28e3-5e2b-8a4c-91fbf8465ae1			b88544ce-50b9-33d9-9cdf-e08f6e012fec	2011-06-01	Warnings	Exact identifier spl id: b6445d2c-28e3-5e2b-8a4c-91fbf8465ae1 spl set id: b88544ce-50b9-33d9-9cdf-e08f6e012fec

Reported adverse events (FAERS/openFDA)#

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