INDICATIONS & USAGE SECTION

Throat Care Formulated for symptoms associated with throat conditions such as dryness, irritation, inflammation, pain and hoarseness.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 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

Aconitum nap. 15x, Apis mel. 15x, Arum dracontium 15x, Belladonna 15x, Bryonia 15x, Cajuputum 15x, Ferrum phosphoricum 15x, Glycyrrhiza glabra 15x, Kali bic.15x, Lachesis 15x, Mentha piperita 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Nitricum ac. 15x, Nux vom.15x, Phosphorus 15x, Phytolacca 15x, Pulsatilla 15x, Spongia 15x, Stannum met. 15x, Sticta 15x, Thuja occ. 15x, Ulmus fulva 15x, Verbascum 15x, Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with throat conditions such as dryness, irritation, inflammation, pain and hoarseness.

INACTIVE INGREDIENT SECTION

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

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

THROAT CARE
aconitum nap., apis mel., arum dracontium, belladonna, bryonia, cajuputum, ferrum phosphoricum, glycyrrhiza glabra, kali bic., lachesis, mentha piperita, merc. viv., naja, nat. carb., nat. sulphuricum, nitricum ac., nux vom., phosphorus, phytolacca, pulsatilla, spongia, stannum met., sticta, thuja occ., ulmus fulva, verbascum, echinacea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2248
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD)	Aconitum Napellus	15 [hp_X] in 1 mL
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z)	Apis Mellifera	15 [hp_X] in 1 mL
Arisaema Dracontium Root (UNII: 73BHJ429FF) (Arisaema Dracontium Root - UNII:73BHJ429FF)	Arisaema Dracontium Root	15 [hp_X] in 1 mL
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H)	Atropa Belladonna	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
Cajuput Oil (UNII: J3TO6BUQ37) (Cajuput Oil - UNII:J3TO6BUQ37)	Cajuput Oil	15 [hp_X] in 1 mL
Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7)	Ferrosoferric Phosphate	15 [hp_X] in 1 mL
Glycyrrhiza Glabra (UNII: 2788Z9758H) (Glycyrrhiza Glabra - UNII:2788Z9758H)	Glycyrrhiza Glabra	15 [hp_X] in 1 mL
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V)	Potassium Dichromate	15 [hp_X] in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I)	Lachesis Muta Venom	15 [hp_X] in 1 mL
Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9)	Mentha Piperita	15 [hp_X] in 1 mL
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL)	Mercury	15 [hp_X] in 1 mL
Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM)	Naja Naja Venom	15 [hp_X] in 1 mL
Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D)	Sodium Carbonate	15 [hp_X] in 1 mL
Sodium Sulfate (UNII: 0YPR65R21J) (Sodium Sulfate Anhydrous - UNII:36KCS0R750)	Sodium Sulfate	15 [hp_X] in 1 mL
Nitric Acid (UNII: 411VRN1TV4) (Nitric Acid - UNII:411VRN1TV4)	Nitric Acid	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
Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG)	Phytolacca Americana Root	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	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
Tin (UNII: 387GMG9FH5) (Tin - UNII:387GMG9FH5)	Tin	15 [hp_X] in 1 mL
Lobaria Pulmonaria (UNII: D1YM0P5Z2T) (Lobaria Pulmonaria - UNII:D1YM0P5Z2T)	Lobaria Pulmonaria	15 [hp_X] in 1 mL
Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397)	Thuja Occidentalis Leafy Twig	15 [hp_X] in 1 mL
Ulmus Rubra Bark (UNII: 91QY4PXU8Q) (Ulmus Rubra Bark - UNII:91QY4PXU8Q)	Ulmus Rubra Bark	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	3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description
Packaging
1	NDC:55714-2248-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2248-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2248-0	.5 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/03/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2248)