teething - colic - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

aconitum napellus (10 [hp_X]) apis mellifera (3 [hp_X]) baptisia tinctoria atropa belladonna borate ion bryonia alba root oyster shell calcium carbonate, crude calcium cation matricaria recutita chelidonium majus arabica coffee bean collinsonia canadensis root citrullus colocynthis fruit pulp wood creosote magnesium cation strychnos nux-vomica seed podophyllum rheum officinale root scutellaria lateriflora silicon dioxide turpentine oil ginger valerian

Inactive Ingredients

sucrose

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2011-03-01

Medication Information

Purpose

Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

Description

Teething - Colic Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

Package Label

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.

Questions Section

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions? 1.800.448.7256

Otc Purpose Section

Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section

Teething - Colic Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

Dosage & Administration Section

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

Otc Active Ingredient Section

Aconitum nap. 10x, Apis mel. 10x, Baptisia 10x, Belladonna 10x, Borax 10x, Bryonia 10x, Calc. carb.10x, Calc. phos. 10x, Chamomilla 10x, Chelidonium majus 10x, Coffea cruda 10x, Collinsonia 10x, Colocynthis 10x, Kreosotum 10x, Mag.phos. 10x, Nux vom. 10x, Podoph. pelt. 10x, Rheum 10x, Scutellaria lateriflora 10x, Silicea 10x, Terebinthina 10x, Zingiber 10x, Chamomilla 3x, Valeriana 3x.

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.

Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions? 1.800.448.7256

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Teething - Colic Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

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

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Aconitum nap. 10x, Apis mel. 10x, Baptisia 10x, Belladonna 10x, Borax 10x, Bryonia 10x, Calc. carb.10x, Calc. phos. 10x, Chamomilla 10x, Chelidonium majus 10x, Coffea cruda 10x, Collinsonia 10x, Colocynthis 10x, Kreosotum 10x, Mag.phos. 10x, Nux vom. 10x, Podoph. pelt. 10x, Rheum 10x, Scutellaria lateriflora 10x, Silicea 10x, Terebinthina 10x, Zingiber 10x, Chamomilla 3x, Valeriana 3x.

Otc Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.

Advanced Ingredient Data

[{"name": "Aconitum Napellus", "unii": "U0NQ8555JD", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Apis Mellifera", "unii": "7S82P3R43Z", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Baptisia Tinctoria", "unii": "5K1UO2888Y", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Atropa Belladonna", "unii": "WQZ3G9PF0H", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Borate Ion", "unii": "44OAE30D22", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Bryonia Alba Root", "unii": "T7J046YI2B", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Oyster Shell Calcium Carbonate, Crude", "unii": "2E32821G6I", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Calcium Cation", "unii": "2M83C4R6ZB", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Matricaria Recutita", "unii": "G0R4UBI2ZZ", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Chelidonium Majus", "unii": "7E889U5RNN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Arabica Coffee Bean", "unii": "3SW678MX72", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Collinsonia Canadensis Root", "unii": "O2630F3XDR", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Citrullus Colocynthis Fruit Pulp", "unii": "23H32AOH17", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Wood Creosote", "unii": "3JYG22FD73", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Magnesium Cation", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Strychnos Nux-vomica Seed", "unii": "269XH13919", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Podophyllum", "unii": "2S713A4VP3", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Rheum Officinale Root", "unii": "A47JP5ZG9M", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Scutellaria Lateriflora", "unii": "7BP4DH5PDC", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Silicon Dioxide", "unii": "ETJ7Z6XBU4", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Turpentine Oil", "unii": "C5H0QJ6V7F", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Ginger", "unii": "C5529G5JPQ", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Valerian", "unii": "JWF5YAW3QW", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "Sucrose", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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. ", "QUESTIONS SECTION": "www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256", "OTC - PURPOSE SECTION": "Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.", "INACTIVE INGREDIENT SECTION": "Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets. ", "INDICATIONS & USAGE SECTION": "Teething - Colic Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.", "DOSAGE & ADMINISTRATION SECTION": "Directions: Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.", "OTC - ACTIVE INGREDIENT SECTION": "Aconitum nap. 10x, Apis mel. 10x, Baptisia 10x, Belladonna 10x, Borax 10x, Bryonia 10x, Calc. carb.10x, Calc. phos. 10x, Chamomilla 10x, Chelidonium majus 10x, Coffea cruda 10x, Collinsonia 10x, Colocynthis 10x, Kreosotum 10x, Mag.phos. 10x, Nux vom. 10x, Podoph. pelt. 10x, Rheum 10x, Scutellaria lateriflora 10x, Silicea 10x, Terebinthina 10x, Zingiber 10x, Chamomilla 3x, Valeriana 3x.", "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."}

teething - colic

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information