Teething - Colic description, usages, side effects, indications, overdosage, supplying and lots more!

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Teething - Colic

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Teething - Colic


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 - 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.  

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

Teething - Colic

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

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-1709
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS ACONITUM NAPELLUS 10 [hp_X]
APIS MELLIFERA APIS MELLIFERA 10 [hp_X]
Baptisia Tinctoria Baptisia Tinctoria 10 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 10 [hp_X]
SODIUM BORATE 10 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 10 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]
TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION 10 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 10 [hp_X]
CHELIDONIUM MAJUS CHELIDONIUM MAJUS 10 [hp_X]
ARABICA COFFEE BEAN Arabica Coffee Bean 10 [hp_X]
COLLINSONIA CANADENSIS ROOT COLLINSONIA CANADENSIS ROOT 10 [hp_X]
CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP 10 [hp_X]
WOOD CREOSOTE WOOD CREOSOTE 10 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION 10 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 10 [hp_X]
Podophyllum Podophyllum 10 [hp_X]
RHEUM OFFICINALE ROOT Rheum Officinale Root 10 [hp_X]
Scutellaria Lateriflora SCUTELLARIA LATERIFLORA 10 [hp_X]
SILICON DIOXIDE 10 [hp_X]
TURPENTINE OIL TURPENTINE OIL 10 [hp_X]
GINGER 10 [hp_X]
Valerian VALERIAN 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-1709-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-1709-2 56.7 in 1 BOTTLE, GLASS
3 NDC:55714-1709-0 7.08 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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