INDICATIONS AND USAGE SECTION

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and other related symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Apis mellifica 15x, Baptisia tinctoria 15x, Belladonna 15x, Borax 15x, Bryonia 15x, Calcarea carbonica 15x, Calcarea phosphorica 15x, Chamomilla 15x, Chelidonium majus 15x, Coffea cruda 15x, Collinsonia canadensis 15x, Colocynthis 15x, Kreosotum 15x, Magnesia phosphorica 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rheum 15x, Scutellaria lateriflora 15x, Silicea 15x, Terebinthina 15x, Zingiber officinale 15x.

OTC - PURPOSE SECTION

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and other related symptoms.

INACTIVE INGREDIENT SECTION

Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

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

WARNINGS: Keep out of reach of children.

PACKAGE LABEL

package label

TEETHING-COLIC
chamomilla, valeriana officinalis, aconitum napellus, apis mellifica, baptisia tinctoria, belladonna, borax, bryonia, calcarea carbonica, calcarea phosphorica, chamomilla, chelidonium majus, coffea cruda, collinsonia canadensis, colocynthis, kreosotum, magnesia phosphorica, nux vomica, podophyllum peltatum, rheum, scutellaria lateriflora, silicea, terebinthina, zingiber officinale pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-1730
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X] in 1 g
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR)	COLLINSONIA CANADENSIS ROOT	15 [hp_X] in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	15 [hp_X] in 1 g
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	15 [hp_X] in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	15 [hp_X] in 1 g
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	15 [hp_X] in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X] in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	15 [hp_X] in 1 g
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	15 [hp_X] in 1 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	15 [hp_X] in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	15 [hp_X] in 1 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	15 [hp_X] in 1 g
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	15 [hp_X] in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	15 [hp_X] in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X] in 1 g
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3)	PODOPHYLLUM	15 [hp_X] in 1 g
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M)	RHEUM OFFICINALE ROOT	15 [hp_X] in 1 g
SCUTELLARIA LATERIFLORA WHOLE (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA WHOLE - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA WHOLE	15 [hp_X] in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 [hp_X] in 1 g
TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F)	TURPENTINE OIL	15 [hp_X] in 1 g
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	15 [hp_X] in 1 g
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	15 [hp_X] in 1 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	15 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-1730-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-1730)

Teething 1730P