Label: LOBELIA PLEX- antimonium sulphuratum aureum, arsenicum iodatum, blatta orientalis, eriodictyon californicum, ipecacuanha, lobelia inflata, natrum sulphuricum, sambucus nigra, senega officinalis liquid
- NDC Code(s): 62106-1195-0
- Packager: Seroyal USA
- 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 November 9, 2022
If you are a consumer or patient please visit this version.
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ACTIVE INGREDIENT
Active ingredients
Each drop contains:
Antimonium sulphuratum aureum (Golden antimony sulfide) 8X
Arsenicum iodatum (Arsenic triiodide) 8X
Blatta orientalis (Indian cockroach) Live Insect 6X
Eriodictyon californicum (Yerba santa) Aerial Parts 3X
Ipecacuanha (Ipecac) Underground Parts 4X
Lobelia inflata (Indian tobacco) Whole Plant 8X
Natrum sulphuricum (Sodium sulfate) 10X
Sambucus nigra (European elder) Leaves and Inflorescences 1X
Senega officinalis (Seneca snakeroot) Root 1X - PURPOSE
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WARNINGS
Warnings
Ask a doctor before use if you have
Persistent 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. - ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
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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.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.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
LOBELIA PLEX
antimonium sulphuratum aureum, arsenicum iodatum, blatta orientalis, eriodictyon californicum, ipecacuanha, lobelia inflata, natrum sulphuricum, sambucus nigra, senega officinalis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1195 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATTA ORIENTALIS (UNII: 535787266D) (BLATTA ORIENTALIS - UNII:535787266D) BLATTA ORIENTALIS 6 [hp_X] in 30 mL ANTIMONY PENTASULFIDE (UNII: 1433F1I86N) (ANTIMONY PENTASULFIDE - UNII:1433F1I86N) ANTIMONY PENTASULFIDE 8 [hp_X] in 30 mL ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE 8 [hp_X] in 30 mL ERIODICTYON CALIFORNICUM LEAF (UNII: 2Y7TIQ135H) (ERIODICTYON CALIFORNICUM LEAF - UNII:2Y7TIQ135H) ERIODICTYON CALIFORNICUM LEAF 3 [hp_X] in 30 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 4 [hp_X] in 30 mL LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA 8 [hp_X] in 30 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 10 [hp_X] in 30 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 1 [hp_X] in 30 mL POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF) POLYGALA SENEGA ROOT 1 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1195-0 1 in 1 CARTON 12/16/2015 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 12/16/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN'UP 401010287 manufacture(62106-1195)
