Label: DROSERA PLEX- arnica montana, belladonna, cina, coccus cacti, corallium rubrum, cuprum metallicum, drosera, ferrum phosphoricum, ipecacuanha, solidago virgaurea liquid
- NDC Code(s): 62106-1194-0
- Packager: Seroyal USA
- 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 July 15, 2021
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ACTIVE INGREDIENT
Active ingredients
Each drop contains:Arnica montana (Leopard's bane) Underground Parts 6X
Belladonna (Deadly nightshade) Whole Plant 6X (<1 x 10-8 % alkaloids, calculated)
Cina (Wormseed) Flower-heads 6X
Coccus cacti (Cochineal) 6X
Corallium rubrum (Red coral) Calcareous Exoskeleton 6X
Cuprum metallicum (Copper) 6X
Drosera (Sundew) Whole Plant 6X
Ferrum phosphoricum (Hydrated iron (III) phosphate) 6X
Ipecacuanha (Ipecac) Underground Parts 6X
Solidago virgaurea (Goldenrod) Inflorescences 2X - PURPOSE
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WARNINGS
Warnings
Ask a doctor before use if you havePersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Cough that is accompanied by excessive phlegm (mucus) or fever.
Stop use and ask a doctor if
Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Symptoms persist or worsen.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.To promote drop flow, invert bottle and shake before each use.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.Adults and adolescents (12 years and older)
Take 10 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)Take under the direction of your healthcare practitioner.
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INDICATIONS & USAGE
Uses
Assists with the temporary relief of cough.Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.To promote drop flow, invert bottle and shake before each use.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.Adults and adolescents (12 years and older)
Take 10 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)Take under the direction of your healthcare practitioner.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DROSERA PLEX
arnica montana, belladonna, cina, coccus cacti, corallium rubrum, cuprum metallicum, drosera, ferrum phosphoricum, ipecacuanha, solidago virgaurea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1194 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 6 [hp_X] in 30 mL ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA FLOWER 6 [hp_X] in 30 mL FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM 6 [hp_X] in 30 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 6 [hp_X] in 30 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 2 [hp_X] in 30 mL DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP 6 [hp_X] in 30 mL ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE 6 [hp_X] in 30 mL ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 6 [hp_X] in 30 mL PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 6 [hp_X] in 30 mL CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON 6 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1194-0 1 in 1 CARTON 12/14/2016 1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/14/2016 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1194)
