Label: PASSIFLORA PLEX- passiflora incarnata, ignatia amara, jalapa, coffea cruda, magnesium metalicum, palladium metallicum, tellurium metallicum, phosphoricum acidum liquid
- NDC Code(s): 52503-1322-0
- Packager: San’Up
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 10, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients
Each drop contains:
Coffea cruda (Coffee) Unroasted Seed 10X
Ignatia amara (St. Ignatius’ bean) Seed 8X
Jalapa (Jalap) Tuber 8X
Magnesium metallicum (Magnesium) 10X
Passiflora incarnata (Passion flower) Aerial Parts 3X
Phosphoricum acidum (Phosphoric acid) 14X
Palladium metallicum (Palladium) 10X
Tellurium metallicum (Tellurium) 10X
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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INDICATIONS & USAGE
UsesFor the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.
Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration.
Directions
To be taken 10 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 6 times daily depending on the severity of symptoms.
Adults and adolescents (12 years and older) Take 10 drops 3 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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DOSAGE & ADMINISTRATION
Directions
To be taken 10 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 6 times daily depending on the severity of symptoms.
Adults and adolescents (12 years and older) Take 10 drops 3 times daily or as recommended by your healthcare practitioner.
Children (under 12 years) .Take under the direction of your healthcare practitioner.
- WARNINGS
- INACTIVE INGREDIENT
- PREGNANCY OR BREAST FEEDING
- STOP USE
- OVERDOSAGE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PASSIFLORA PLEX
passiflora incarnata, ignatia amara, jalapa, coffea cruda, magnesium metalicum, palladium metallicum, tellurium metallicum, phosphoricum acidum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52503-1322 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] in 30 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 10 [hp_X] in 30 mL MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM 10 [hp_X] in 30 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 8 [hp_X] in 30 mL IPOMOEA PURGA ROOT (UNII: 4UDO46YBK2) (IPOMOEA PURGA ROOT - UNII:4UDO46YBK2) IPOMOEA PURGA ROOT 8 [hp_X] in 30 mL PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M) PALLADIUM 10 [hp_X] in 30 mL TELLURIUM (UNII: NQA0O090ZJ) (TELLURIUM - UNII:NQA0O090ZJ) TELLURIUM 10 [hp_X] in 30 mL PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 14 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 12.07 g in 30 mL ALCOHOL (UNII: 3K9958V90M) 14.94 g in 30 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52503-1322-0 1 in 1 CARTON 02/09/2015 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 drug other 02/09/2015 Labeler - San’Up (401010287) Establishment Name Address ID/FEI Business Operations San’Up 401010287 manufacture(52503-1322)
