HENDEL INSOMNIA RELIEF- passiflora incarnata flowering top, ambergris, scutellaria lateriflora, zinc valerate dihydrate, anamirta cocculus seed, and arabica coffee bean tablet

Hendel Insomnia Relief by

Drug Labeling and Warnings

Hendel Insomnia Relief by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if sensitivity to Insomnia Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

ACTIVE INGREDIENT

Each tablet contains equal parts of Passiflora incarnata 2X; Amber grisea 6X; Scutellaria lateriflora 6X; Zincum valerianicum 6X; Cocculus indicus 12X; Coffea cruda 12X

INACTIVE INGREDIENT

Lactose, Magnesium stearate

Directions

Adults 18 and over: 1 to 2 tablets sublingually or dissolved completely in mouth 30 to 60 minutes before going to bed or as directed
by a physician.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

For the temporary relief of:
Occasional Nervous Restlessness
Occasional Sleeplessness
Frequent Awakening

PURPOSE

Insomnia Relief

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HENDEL INSOMNIA RELIEF 
passiflora incarnata flowering top, ambergris, scutellaria lateriflora, zinc valerate dihydrate, anamirta cocculus seed, and arabica coffee bean tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-1120
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	2 [hp_X]
AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C)	AMBERGRIS	6 [hp_X]
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA	6 [hp_X]
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B)	ZINC VALERATE DIHYDRATE	6 [hp_X]
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	12 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	leafman
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62795-1120-4	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/31/2016

Labeler - MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
MediNatura Inc		102783016	manufacture(62795-1120)