HENDEL HOMEOPATHIC CALM- avena sativa flowering top, matricaria chamomilla, hops, passiflora incarnata flowering top, zinc valerate dihydrate, arabica coffee bean, strychnos nux-vomica seed, and sulfur tablet

Hendel Homeopathic Calm by

Drug Labeling and Warnings

Hendel Homeopathic Calm 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 symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Homeopathic Calm or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS

Restlessness Occasional and simple nervous tension

ACTIVE INGREDIENTS

Each tablet contains equal parts of Avena sativa 2X; Chamomilla 2X; Humulus lupulus 2X; Passiflora incarnata 2X; Zincum valerianicum 6X; Coffea cruda 12X; Nux vomica 12X; Sulphur 12X

INACTIVE INGREDIENT

Lactose, Magnesium stearate

DOSAGE

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

USES

For the temporary relief of:
Restlessness
Occasional simple nervous tension

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HENDEL HOMEOPATHIC CALM 
avena sativa flowering top, matricaria chamomilla, hops, passiflora incarnata flowering top, zinc valerate dihydrate, arabica coffee bean, strychnos nux-vomica seed, and sulfur tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-1118
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	2 [hp_X]
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	2 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X]
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B)	ZINC VALERATE DIHYDRATE	6 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	12 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	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: 62795-1118-2	100 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	08/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/01/2016

Labeler - MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
MediNatura Inc		102783016	manufacture(62795-1118)