Label: TRIPLE COMPLEX SLEEP TONIC- calc phos, clac sulph, mag phos liquid

  • 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 December 25, 2023

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  • HPUS Active Ingredients

    HPUS Active Ingredients: Equal volumes of each ingredient in an 8X potency: Calc phos, Calc sulph, Mag phos.

    The letters HPUS indicated that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • *Uses

    Uses*: Homeopathic remedy for peaceful slumber & sleep routine.

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • Warnings

    Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach or childern. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions: Mix in 1/4 cup water and sip slowly. Alternatively, drops may be taken directly into mouth. For all ages: Acute: Take 0.25-0.50 mL every hour, up to 10 doses, until symptoms improve. Chronic: Take 0.25-0.50 mL 3 times daily.

  • OTHER SAFETY INFORMATION

    Contains no artificial flavors or colorants. No gluten added.

    Tamper resistant for your protection. Use only if safety seal is intact.

  • Inactive Ingredients

    Inactive Ingredients: USP grain alcohol(20% by volume), purified water, sucrose.

  • KEEP OUT OF REACH OF CHILDREN

  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    Relieves sleeplessness in all ages

  • PRINCIPAL DISPLAY PANEL

    Triple Complex Sleep Tonic

  • INGREDIENTS AND APPEARANCE
    TRIPLE COMPLEX SLEEP TONIC 
    calc phos, clac sulph, mag phos liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-388
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]  in 59 mL
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE8 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-388-0259 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/09/2023
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma030572478manufacture(68703-388)
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