Label: 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

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated August 18, 2022

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  • 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

    Dr. Hendel Calm Plus

    Add image transcription here...

  • 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 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)
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