COLD - COUGH- influenza a virus, influenza b virus, antimon. tart., arsenicum alb., bryonia, chelidonium majus, cinchona, drosera, eucalyptus, histaminum hydrochloricum, hydrastis, kali bic., kali carb.,kali iod., myrrha, nat. sulphuricum, nux vom., phosphorus, pulsatilla, rumex crisp., sambucus nig., spongia, tussilago farfara, verbascum, echinacea, lappa liquid

Cold - Cough by

Drug Labeling and Warnings

Cold - Cough by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE SECTION

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Lappa 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium majus 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig.15x, Spongia 15x, Tussilago farfara 15x, Verbascum 15x, Influenzinum 30x.

OTC - PURPOSE SECTION

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If ​pregnant or breast-feeding,​ ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

COLD - COUGH 
influenza a virus, influenza b virus, antimon. tart., arsenicum alb., bryonia, chelidonium majus, cinchona, drosera, eucalyptus, histaminum hydrochloricum, hydrastis, kali bic., kali carb.,kali iod., myrrha, nat. sulphuricum, nux vom., phosphorus, pulsatilla, rumex crisp., sambucus nig., spongia, tussilago farfara, verbascum, echinacea, lappa liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-4767
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E)	INFLUENZA A VIRUS	30 [hp_X]  in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X]  in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	15 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	15 [hp_X]  in 1 mL
DROSERA ANGLICA (UNII: J61BY05EGY) (DROSERA ANGLICA - UNII:J61BY05EGY)	DROSERA ANGLICA	15 [hp_X]  in 1 mL
EUCALYPTUS GUM (UNII: 72T9EZC2VX) (EUCALYPTUS GUM - UNII:72T9EZC2VX)	EUCALYPTUS GUM	15 [hp_X]  in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	15 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	15 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	15 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	15 [hp_X]  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	15 [hp_X]  in 1 mL
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)	MYRRH	15 [hp_X]  in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	15 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	ANEMONE PULSATILLA	15 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	15 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	15 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	15 [hp_X]  in 1 mL
TUSSILAGO FARFARA (UNII: 0JXZ63016V) (TUSSILAGO FARFARA - UNII:0JXZ63016V)	TUSSILAGO FARFARA	15 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	15 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X]  in 1 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3)	ARCTIUM LAPPA ROOT	6 [hp_X]  in 1 mL
INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA B VIRUS - UNII:1314JZ2X6W)	INFLUENZA B VIRUS	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4767-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/02/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-4767)