OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

QUESTIONS SECTION

newtonlabs.net - Questions? 800 448-7256

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

INACTIVE INGREDIENT SECTION

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Apis mel. 15x, Asterias 15x, Belladonna 15x, Bryonia 15x, Bufo 15x, Calc. carb. 15x, Chamomilla 15x, Chimaphila umb. 15x, Cinchona 15x, Conium 15x, Croton 15x, Echinacea 15x, Graphites 15x, Helonias 15x, Lachesis 15x, Merc. viv. 15x, Phellandrium 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Sanguinaria 15x, Silicea 15x.

DOSAGE & ADMINISTRATION SECTION

Ages 12 and up take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

PACKAGE LABEL

package label

BREAST CARE
bufo rana, apis mel., asterias rubens, belladonna, bryonia, calc. carb., chamomilla, chimaphila umbellata, cinchona, conium, croton, echinacea, graphites, helonias dioica, lachesis, merc. viv., phellandrium aquaticum phosphorus, phytolacca, pulsatilla, sanguinaria, silicea, hamamelis, ruta, taraxacum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2394
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q)	BUFO BUFO CUTANEOUS GLAND	15 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	15 [hp_X] in 1 mL
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742)	ASTERIAS RUBENS	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
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	15 [hp_X] in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	15 [hp_X] in 1 mL
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J)	CHIMAPHILA UMBELLATA	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
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	15 [hp_X] in 1 mL
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E)	CROTON TIGLIUM SEED	15 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	15 [hp_X] in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	15 [hp_X] in 1 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U)	CHAMAELIRIUM LUTEUM ROOT	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
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	15 [hp_X] in 1 mL
OENANTHE AQUATICA FRUIT (UNII: N4LEE4Z93J) (OENANTHE AQUATICA FRUIT - UNII:N4LEE4Z93J)	OENANTHE AQUATICA FRUIT	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
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	15 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 [hp_X] in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	6 [hp_X] in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	6 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-2394-0	15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/05/2018	08/01/2019
2	NDC:55714-2394-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/05/2018
3	NDC:55714-2394-2	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/05/2018	08/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/05/2018

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2394)

Breast 2394L