Label: CHILDRENS COUGH- aconitum napellus, bromium, coccus cacti, corallium rubrum, cuprum metallicum, drosera, hepar sulphuris calcareum, iodium, mephitis mephitica, spongia tosta liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0145-2 - 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 December 13, 2016
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Aconitum napellus, Bromium, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera, Hepar sulphuris calcareum, Iodium, Mephitis mephitica, Spongia tosta. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.
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INDICATIONS & USAGE
Uses for temporary relief of minor cough symptoms: dry or hoarse cough, tickling cough, cough from mucus drainage or throat irritation. Note: A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, stop use and consult a health care professional.
- INACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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PURPOSE
Uses for temporary relief of minor cough symptoms:
- dry or hoarse cough
- tickling cough
- cough from mucus drainage or throat irritation
- Note: A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, stop use and consult a health care professional.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS COUGH
aconitum napellus, bromium, coccus cacti, corallium rubrum, cuprum metallicum, drosera, hepar sulphuris calcareum, iodium, mephitis mephitica, spongia tosta liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0145 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 BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE 10 [hp_X] in 59 mL PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 10 [hp_X] in 59 mL CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON 10 [hp_X] in 59 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 10 [hp_X] in 59 mL DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA 10 [hp_X] in 59 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 10 [hp_X] in 59 mL IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 10 [hp_X] in 59 mL MEPHITIS MEPHITIS ANAL GLAND FLUID (UNII: 3BN57UN4US) (MEPHITIS MEPHITIS ANAL GLAND FLUID - UNII:3BN57UN4US) MEPHITIS MEPHITIS ANAL GLAND FLUID 10 [hp_X] in 59 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 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:57955-0145-2 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/22/2012 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(57955-0145)