Label: NEWBORN TONIC- aconitum napellus, bovista, bryonia, chamomilla, cinchona officinalis, lupulinum, mercurius vivus, myrica cerifera, natrum sulphuricum, phosphorus, sepia liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0114-2 - Packager: King Bio 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 19, 2015
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Aconitum napellus, Bovista, Bryonia, Chamomilla, Cinchona officinalis, Lupulinum, Mercurius vivus, Myrica cerifera, Natrum sulphuricum, Phosphorus, Sepia. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- WARNINGS
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- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
NEWBORN TONIC
aconitum napellus, bovista, bryonia, chamomilla, cinchona officinalis, lupulinum, mercurius vivus, myrica cerifera, natrum sulphuricum, phosphorus, sepia liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0114 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 10 [hp_X] in 59 mL LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY 10 [hp_X] in 59 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 10 [hp_X] in 59 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 59 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 10 [hp_X] in 59 mL HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 10 [hp_X] in 59 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 10 [hp_X] in 59 mL MORELLA CERIFERA ROOT BARK (UNII: S46HJ3710D) (MORELLA CERIFERA ROOT BARK - UNII:S46HJ3710D) MORELLA CERIFERA ROOT BARK 10 [hp_X] in 59 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 10 [hp_X] in 59 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 59 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0114-2 59 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/22/2012 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0114)