CALM PLUS- avena sativa flowering top, matricaria recutita, passiflora incarnata flowering, tribasic calcium phosphate, dibasic potassium phosphate, potassium sulfate, magnesium phosphate, dibasic, sodium chloride, sodium sulfate, zinc valerate dihydrate, arabica coffee bean, strychnos nux-vomica seed, and sulfur tablet

Calm Plus by

Drug Labeling and Warnings

Calm Plus by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

If symptoms persist or worsen, or 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 Calm Plus 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

USES

For the temporary relief of:

Simple nervous tension

Restlessness

Trouble sleeping

ACTIVE INGREDIENTS

Active Ingredients:

Each tablet contains equal parts of Avena sativa 2X; Chamomilla 2X; Humulus lupulus 2X; Passiflora incarnata 2X; Calcarea phosphorica 6X; Kali phosphoricum 6X; Kali sulphuricum 6X; Magnesia phosphorica 6X; Natrum muriaticum 6X; Natrum sulphuricum 6X; Zincum valerianicum 6X; Coffea cruda 12X; Nux vomica 12X; Sulphur 12X

INACTIVE INGREDIENTS

Inactive Ingredients:

Lactose, Magnesium stearate

DIRECTIONS

Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.

PURPOSE

For the temporary relief of:

Simple nervous tension

Restlessness

Trouble sleeping

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALM PLUS 
avena sativa flowering top, matricaria recutita, passiflora incarnata flowering, tribasic calcium phosphate, dibasic potassium phosphate, potassium sulfate, magnesium phosphate, dibasic, sodium chloride, sodium sulfate, zinc valerate dihydrate, arabica coffee bean, strychnos nux-vomica seed, and sulfur tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-1115
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 RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	2 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	2 [hp_X]
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	6 [hp_X]
POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG)	POTASSIUM SULFATE	6 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC (UNII: A1Y870209Z) (MAGNESIUM PHOSPHATE, DIBASIC - UNII:A1Y870209Z)	MAGNESIUM PHOSPHATE, DIBASIC	6 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	6 [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	RECTANGLE	Size	9mm
Flavor		Imprint Code	Leafman
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62795-1115-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2016

Labeler - MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
MediNatura Inc		102783016	manufacture(62795-1115)