Label: BEDWETTING- belladonna, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium, humulus, kali phos., lycopodium, nat.mur., plantago, pulsatilla, rhus aromatica, sabal, thyroidinum, verbascum, echinacea, hydrastis, passiflora, valeriana liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-1513-0, 55714-1513-1, 55714-1513-2 - 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 March 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
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DOSAGE & ADMINISTRATION SECTION
Directions: ORAL USE ONLY - SHAKE WELL. Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
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OTC - ACTIVE INGREDIENT SECTION
Belladonna 15x, Cantharis 15x ,Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium 15x, Humulus 15x, Kali phos. 15x, Lycopodium 15x, Nat.mur. 15x, Plantago 15x, Pulsatilla 15x, Rhus aromatica 15x,Sabal 15x, Thyroidinum 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x, Passiflora 3x, Valeriana 3x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - 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
BEDWETTING
belladonna, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium, humulus, kali phos., lycopodium, nat.mur., plantago, pulsatilla, rhus aromatica, sabal, thyroidinum, verbascum, echinacea, hydrastis, passiflora, valeriana liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1513 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 15 [hp_X] in 1 mL Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 15 [hp_X] in 1 mL Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum 15 [hp_X] in 1 mL Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale 15 [hp_X] in 1 mL Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 15 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 15 [hp_X] in 1 mL Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83) Hops 15 [hp_X] in 1 mL Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR) Potassium Phosphate, Dibasic 15 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 mL Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 15 [hp_X] in 1 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 15 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 15 [hp_X] in 1 mL Rhus Aromatica Root Bark (UNII: Q3H36W0J42) (Rhus Aromatica Root Bark - UNII:Q3H36W0J42) Rhus Aromatica Root Bark 15 [hp_X] in 1 mL Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto 15 [hp_X] in 1 mL Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P) Thyroid, Unspecified 15 [hp_X] in 1 mL Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 15 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 mL Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 3 [hp_X] in 1 mL Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top 3 [hp_X] in 1 mL Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-1513-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-1513-2 59.14 mL in 1 BOTTLE, GLASS 3 NDC:55714-1513-0 .5 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-1513)