Label: AHH SLEEP- coffea cruda spray

  • NDC Code(s): 83018-0004-1
  • Packager: Micro Balance Health Products
  • 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 October 30, 2023

If you are a consumer or patient please visit this version.

  • Indication

    Temporarily relieves symptoms associated with sleeplessness such as the inability to fall asleep or return to sleep after waking, restlessness, nervousness, worry, and excitability, to restore a more natural sleep pattern.

  • Directions

    Adults and children over 12: Apply 2-4 sprays under the tongue before bedtime. For best results, hold spray under the tongue 15 seconds before swallow. Addtional sprays may be taken during the night as needed. Do not take within 15 minutes of consuming food or brushing teeth.

  • Active ingredients

    Coffea cruda (coffee) 200 C;

    Cypripedium ( Lady's Slipper Orchid) 4x,

    Hyoscyamus Niger (Henbane) 30C;

    Ignatia Amara 12X;

    Kalium Phosphoricum (Potassium Phosphate) 12X,

    Muriaticum Acidum (Muriatic Acid) 12X;

    Sulphur 6X;

    Zincum Metallicum (Zinc) 12X

  • Inactive Ingredients

    Alcohol USP 20%;

    Water

  • Warnings

    If you are pregnant, breastfeeding, or for use in children under 12, consult with a helthcare prefessional. In case of accidental overdose, get medical help or contact a Posion Control Center right away. If symptoms worsen or persist for more than 2 weeks, consult a physician.

    If you are pregnant, breastfeeding, or for use in children under 12, consult with a helthcare prefessional. In case of accidental overdose, get medical help or contact a Posion Control Center right away. If symptoms worsen or persist for more than 2 weeks, consult a physician.

    Do not use

    Do not use if tamper evident seal is broken or missing. Store in a cool place after opening.

    Keep out of reach of children

  • SPL UNCLASSIFIED SECTION

    Micro balance Health Products

    Doctor Formulated

    Homeopathic Sleep Support

    Ahh Sleep

    Restful Nights, Brighter Days

    Melationin-free. No next -day grogginess. Non-habit forming.

    Alcohol USP20%

    1 fl oz(30ml)

  • PURPOSE

    Temporarily relieves symptoms associated with sleeplessness such as the inability to fall asleep or return to sleep after waking, restlessness, nervousness, worry, and excitability, to restore a more natural sleep pattern.

  • label

    label

  • INGREDIENTS AND APPEARANCE
    AHH SLEEP 
    coffea cruda spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83018-0004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT4 [hp_X]  in 1 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB) HYDROCHLORIC ACID12 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN200 [hp_C]  in 1 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]  in 1 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 1 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER30 [hp_C]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) (POTASSIUM PHOSPHATE, UNSPECIFIED FORM - UNII:B7862WZ632) POTASSIUM PHOSPHATE, UNSPECIFIED FORM12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83018-0004-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/30/2023
    Labeler - Micro Balance Health Products (025495088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorie Schmidt-Nagel203869883manufacture(83018-0004)