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.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Cold - Cough

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

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

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

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

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

Keep out of reach of children

PACKAGE LABEL.

package label

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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4421
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Influenza A Virus (UNII: R9HH0NDE2E) (Influenza A Virus - UNII:R9HH0NDE2E) Influenza A Virus35 [hp_X]  in 1 g
American Ginseng (UNII: 8W75VCV53Q) (American Ginseng - UNII:8W75VCV53Q) American Ginseng20 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide20 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root20 [hp_X]  in 1 g
Euphrasia Stricta (UNII: C9642I91WL) (Euphrasia Stricta - UNII:C9642I91WL) Euphrasia Stricta20 [hp_X]  in 1 g
Gaultheria Procumbens Top (UNII: 830295X963) (Gaultheria Procumbens Top - UNII:830295X963) Gaultheria Procumbens Top20 [hp_X]  in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root20 [hp_X]  in 1 g
Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide20 [hp_X]  in 1 g
Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride20 [hp_X]  in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal20 [hp_X]  in 1 g
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate20 [hp_X]  in 1 g
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury20 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus20 [hp_X]  in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris20 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf20 [hp_X]  in 1 g
Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon Officinale Seed20 [hp_X]  in 1 g
Sage (UNII: 065C5D077J) (Sage - UNII:065C5D077J) Sage20 [hp_X]  in 1 g
Lobaria Pulmonaria (UNII: D1YM0P5Z2T) (Lobaria Pulmonaria - UNII:D1YM0P5Z2T) Lobaria Pulmonaria20 [hp_X]  in 1 g
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus20 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified8 [hp_X]  in 1 g
Influenza B Virus (UNII: 1314JZ2X6W) (Influenza B Virus - UNII:1314JZ2X6W) Influenza B Virus35 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4421-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-4421-256.7 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4421)

Revised: 6/2011
Document Id: b6445d2c-28e3-5e2b-8a4c-91fbf8465ae1
Set id: b88544ce-50b9-33d9-9cdf-e08f6e012fec
Version: 2
Effective Time: 20110601
 
Newton Laboratories, Inc.