PASSIFLORA INCARNATA- passion flower granule

PASSIFLORA INCARNATA by

Drug Labeling and Warnings

PASSIFLORA INCARNATA by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN’UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

PASSIFLORA INCARNATA 30K GR

PASSIFLORA INCARNATA 4CH GR

PASSIFLORA INCARNATA 6CH GR

PURPOSE

Indications

For the temporary relief of sleeplessness and restlessness

WARNINGS

Warning:
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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

INACTIVE INGREDIENT

Inactive Ingredients
Lactose,
sucrose.

DOSAGE & ADMINISTRATION

Directions
Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
Children: Take three granules and follow adult directions.

QUESTIONS

QUESTIONS? 1-888-737-6925.

INDICATIONS & USAGE

Indications

For the temporary relief of sleeplessness and restlessness

Directions
Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
Children: Take three granules and follow adult directions.

PRINCIPAL DISPLAY PANEL

UNDA
Do not use if label perforation is broken
Homeopathic Remedy
NDC : 62106-8562-4
PASSIFLORA INCARNATA
Passion flower
140 granules
Indications

For the temporary relief of sleeplessness and restlessness

INGREDIENTS AND APPEARANCE

PASSIFLORA INCARNATA 
passion flower granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-8562
Route of Administration	ORAL

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	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-8562-4	10 in 1 CARTON	05/28/2015
1		140 in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/28/2015

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN’UP		401010287	manufacture(62106-8562)