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
- NDC Code(s): 55714-1730-1
- Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated February 3, 2020
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- INDICATIONS AND USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
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 pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1730 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-1730-1 28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-1730)
