Label: INSOMNIA RELIEF pellet

  • NDC Code(s): 61727-307-21
  • Packager: Homeocare Laboratories
  • 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 December 26, 2018

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  • Active Ingredients:

    Avena sativa 3X, Coffea cruda 14x, Chamomilla 8X, Passiflora incarnata 8X, Stramonium 8X, Nux vomica 8X.

  • Purpose:

    For the temporary relief of insomnia due to stress, worry, grief or excess caffeine; restlessness and night terrors in children.

  • Keep out of reach of children.

    Keep out of reach of children.

  • Indications & Usage:

    Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times/day & at bedtime or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

  • Warnings:

    If symptoms persist or worsen, or if pregnant or nursing, consult a doctor. Keep out of reach of children. Do not use if cap seal is broken or missing.

  • Dosage & Administration:

    Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times/day & at bedtime or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

  • Inactive ingredients:

  • Insomnia Relief

    hcl_label_insomnia 2012.jpg

  • INGREDIENTS AND APPEARANCE
    INSOMNIA RELIEF 
    insomnia relief pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61727-307
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]  in 4 g
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN14 [hp_X]  in 4 g
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA8 [hp_X]  in 4 g
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP8 [hp_X]  in 4 g
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM8 [hp_X]  in 4 g
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED8 [hp_X]  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61727-307-214 g in 1 TUBE; Type 0: Not a Combination Product07/20/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/20/2012
    Labeler - Homeocare Laboratories (088248828)
    Registrant - Homeocare Laboratories (088248828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Homeocare Laboratories088248828manufacture(61727-307)
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