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 
MediNatura Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Dr. Hendel Calm Plus

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

Dr. Hendel Calm Plus

Add image transcription here...

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1115
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA2 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION2 [hp_X]
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE6 [hp_X]
POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE6 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC (UNII: A1Y870209Z) (MAGNESIUM PHOSPHATE, DIBASIC - UNII:A1Y870209Z) MAGNESIUM PHOSPHATE, DIBASIC6 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE6 [hp_X]
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE6 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN12 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLESize9mm
FlavorImprint Code Leafman
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62795-1115-2100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/201604/30/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/01/201604/30/2026
Labeler - MediNatura Inc (079324099)
Establishment
NameAddressID/FEIBusiness Operations
MediNatura Inc102783016manufacture(62795-1115)

Revised: 8/2022
Document Id: c0eeb7b9-388c-410e-a8d0-00e2860b16e0
Set id: 23b540c5-ed00-4858-b23e-33537969a03e
Version: 3
Effective Time: 20220818
 
MediNatura Inc