Search by Drug Name or NDC

NDC 52503-1322-00 PASSIFLORA PLEX 10; 8; 10; 10; 3; 14; 8; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

PASSIFLORA PLEX 10; 8; 10; 10; 3; 14; 8; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

PASSIFLORA PLEX is a SUBLINGUAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by San. The primary component is ARABICA COFFEE BEAN; IPOMOEA PURGA ROOT; MAGNESIUM; PALLADIUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; STRYCHNOS IGNATII SEED; TELLURIUM.

Product Information

NDC	52503-1322
Product ID	52503-1322_d06cb8b2-b26e-95ad-e053-2995a90aa3b0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PASSIFLORA PLEX
Proprietary Name Suffix	n/a
Non-Proprietary Name	Passiflora incarnata, Ignatia amara, Jalapa, Coffea cruda, Magnesium metalicum, Palladium metallicum, Tellurium metallicum, Phosphoricum acidum
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	SUBLINGUAL
Active Ingredient Strength	10; 8; 10; 10; 3; 14; 8; 10
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ARABICA COFFEE BEAN; IPOMOEA PURGA ROOT; MAGNESIUM; PALLADIUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; STRYCHNOS IGNATII SEED; TELLURIUM
Labeler Name	San
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52503-1322-00 (52503132200)

Pricing Information	N/A
NDC Package Code	52503-1322-0
Billing NDC	52503132200
Package	1 BOTTLE, GLASS in 1 CARTON (52503-1322-0) / 30 mL in 1 BOTTLE, GLASS
Marketing Start Date	2015-02-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 937b6700-3ba8-0266-e053-2995a90a3318 Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Uses

For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

SPL UNCLASSIFIED SECTION

Uses

For 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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Warnings

Stop use and ask a doctor if 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.

SPL UNCLASSIFIED SECTION

Inactive ingredients

Ethanol (beet), purified water

SPL UNCLASSIFIED SECTION

If pregnant or breastfeeding, ask a health professional before use.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if symptoms persist or worsen.

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Do not use if seal is missing or broken.

Store in a cool, dry place.

Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.

PRINCIPAL DISPLAY PANEL

NDC 62106-1322-0

UNDA

PLEX

PASSIFLORA PLEX

Homeopathic Preparation

For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

Contains 60% Alcohol

30 mL (1 fl oz)

INGREDIENTS AND APPEARANCE

PASSIFLORA PLEX

passiflora incarnata, ignatia amara, jalapa, coffea cruda, magnesium metalicum, palladium metallicum, tellurium metallicum, phosphoricum acidum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52503-1322
Route of Administration	SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	12.07 g in 30 mL
ALCOHOL (UNII: 3K9958V90M)	14.94 g in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/09/2015

Labeler - San’Up (401010287)

Name	Address	ID/FEI	Business Operations
Establishment
San’Up		401010287	manufacture(52503-1322)

Revised: 11/2021

Document Id: d06cb8b2-b26e-95ad-e053-2995a90aa3b0

Set id: 937b6700-3ba8-0266-e053-2995a90a3318

Version: 4

Effective Time: 20211110

Search by Drug Name or NDC

NDC 52503-1322-00 PASSIFLORA PLEX 10; 8; 10; 10; 3; 14; 8; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

PASSIFLORA PLEX 10; 8; 10; 10; 3; 14; 8; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 52503-1322-00 (52503132200)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 937b6700-3ba8-0266-e053-2995a90a3318 Details

SPL UNCLASSIFIED SECTION

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SPL UNCLASSIFIED SECTION

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SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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