Label: SLEEP ASSIST- chamomilla, coffea cruda, avena sativa, nux vomica, passiflora incarnata tablet, orally disintegrating

  • NDC Code(s): 43689-0018-1, 43689-0018-2
  • Packager: The Magni Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 June 19, 2023

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  • ACTIVE INGREDIENTS:

    (in each tablet) Avena Sativa 6X, Chamomilla 4X, Coffea Cruda 4X, Nux Vomica 6X, Passiflora Incarnata 6X.

  • PURPOSE:

    Avena Sativa – For sleeplessness, Chamomilla – For irritability, sleeplessness, and restlessness, Coffea Cruda – For sleeplessness when the mind is awake, Nux Vomica- For those who awake early and cannot get back to sleep, Passiflora Incarnata – For restlessness due to exhaustion.

  • USES:

    Nighttime sleep aid

  • WARNINGS:


    • If pregnant or breastfeeding, ask a health professional before use.

    • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN:

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    • Adults and children 12 years and above, dissolve 1 to 3 tablets under tongue 1/2 to 1 hour before bedtime.

    • Children under 12 years, consult a physician.

  • OTHER INFORMATION:

    Store tightly closed in a dry place

    • Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

    • The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United

    States

    • These statements are supported by the traditional homeopathic principles

  • INACTIVE INGREDIENT

    Lactose, Magnesium Stearate, Microcrystaline Cellulose.

  • QUESTIONS:

    Dist. by:

    The Magni Group, Inc.

    McKinney, TX 75071 USA

    www.magnilife.com

    1-800-645-9199

  • PACKAGE LABEL DISPLAY:

    MAGNILIFE®         HOMEOPATHIC 

    SLEEP ASSIST       NDC 43689-0018-1

    For sleeplessness and

    difficulty falling asleep

    125 Tablets

    SLEEP ASSIST LBL

    SLEEP ASSIST CTN

  • INGREDIENTS AND APPEARANCE
    SLEEP ASSIST 
    chamomilla, coffea cruda, avena sativa, nux vomica, passiflora incarnata tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE4 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN4 [hp_X]
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP6 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Convex) Size6mm
    FlavorImprint Code ML
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43689-0018-21 in 1 CARTON06/19/2023
    1NDC:43689-0018-1125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/19/2023
    Labeler - The Magni Company (113501902)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43689-0018) , api manufacture(43689-0018) , label(43689-0018) , pack(43689-0018)
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