Label: PMS HP- atropa belladonna, lachesis muta venom, magnesium phosphate, dibasic trihydrate, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, sepia officinalis juice 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 November 12, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Belladonna 30X, Lachesis Mutus 30X, Magnesia Phosphorica 30X, Natrum Muriaticum 30X, Nux Vomica 30X, Pulsatilla 30X, Sepia 30X

  • INDICATIONS & USAGE

    USES: Temporarily relieves uterine & ovarian pains, menstrual cramps, cutting pains, aversion to sex, &/or other symptoms related to PMS.

  • WARNINGS

    WARNING:

    Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

  • DO NOT USE

    OTHER INFORMATION: Tamper Seal: "Sealed for your protection."

    Do not use if seal is broken or missing.

  • REFERENCES

    *The letters "HPUS" indicate the components in thye product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

  • QUESTIONS

    QUESTIONS AND COMMENTS?

    MFG FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600

    LOT:

  • PURPOSE

    USES: Temporarily relieves uterine & ovarian pains, menstrual cramps, cutting pains, aversion to sex, &/or other symptoms related to PMS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0037-1

    PMS HP

    PMS

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    Image Of Label

  • INGREDIENTS AND APPEARANCE
    PMS HP 
    atropa belladonna, lachesis muta venom, magnesium phosphate, dibasic trihydrate, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, sepia officinalis juice liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0037
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION30 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) CHLORIDE ION30 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0037-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0037)
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