Label: CHILDRENS COUGH SYMPTOM FORMULA- aconitum napellus, bromium, coccus cacti, corallium rubrum, cuprum metallicum, drosera, hepar sulphuris calcareum, iodium, mephitis mephitica and spongia tosta liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-7145-1 - Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
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 February 14, 2013
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- Active Ingredients
- Inactive Ingredient
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Purpose
HPUS active ingredients Purpose†
Equal volumes of each ingredient in 10X, 30X and LM1 Potencies.
Aconitum napellus.........................................................shortness of breath, hoarse cough
Bromium........................................................................rattling cough with mucus
Coccus cacti...................................................................tickling in the throat
Corallium rubrum...........................................................rapid cough, profuse mucus
Cuprum metallicum........................................................tight chest, gurgling cough
Drosera.........................................................................deep, hoarse cough
Hepar sulphuris calcareum..............................................wheezing, choking cough
Iodium...........................................................................dry cough
Mephitis mephitica.........................................................violent coughing
Spongia tosta................................................................difficult breathing, dry throat, chest feels weak
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Warnings
- If cough persists more than 7 days, or is accompanied by fever, rash, or persistent headache, stop use and consult physician. Note: A persistent cough may be a sign of a serious condition.
- If pregnant or breast-feeding, ask a healthcare professional before use.
- Keep out of reach of children.
Other information: Tamper resistant for your protection. Use only if safety seal is intact.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS COUGH SYMPTOM FORMULA
aconitum napellus, bromium, coccus cacti, corallium rubrum, cuprum metallicum, drosera, hepar sulphuris calcareum, iodium, mephitis mephitica and spongia tosta liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-7145 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 29.6 mL BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE 10 [hp_X] in 29.6 mL PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 10 [hp_X] in 29.6 mL CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON 10 [hp_X] in 29.6 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 10 [hp_X] in 29.6 mL DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA 10 [hp_X] in 29.6 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 10 [hp_X] in 29.6 mL IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 10 [hp_X] in 29.6 mL MEPHITIS MEPHITIS ANAL GLAND FLUID (UNII: 3BN57UN4US) (MEPHITIS MEPHITIS ANAL GLAND FLUID - UNII:3BN57UN4US) MEPHITIS MEPHITIS ANAL GLAND FLUID 10 [hp_X] in 29.6 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 10 [hp_X] in 29.6 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-7145-1 1 in 1 CARTON 1 29.6 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/11/2013 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 api manufacture(57955-7145)