Label: GUNA-PMS- arsenic trioxide - estradiol - goldenseal - lachesis muta venom - magnesium phosphate - matricaria recutita - melatonin - progesterone - strychnos nux-vomica seed - sulfur - sus scrofa ovary - sus scrofa pituitary gland - solution/ drops

  • 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 21, 2018

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  • ACTIVE INGREDIENTS/PURPOSE

    ARSENICUM ALBUM 6C MOOD SUPPORT

    BETA-ESTRADIOL 6X VAGINAL DRYNESS

    CHAMOMILLA 6C CALMING

    HYDRASTIS CANADENSIS 6C ANALGESIC

    HYPOPHYSIS 8X HORMONAL REGULATION

    LACHESIS MUTUS 4C ANXIETY

    MAGNESIA PHOSPHORICA 6C METABOLIC SUPPORT

    MELATONIN 4C HORMONAL BALANCE

    NUX VOMICA 6C MOOD SUPPORT

    OOPHORINUM 8X IRREGULAR MENSES

    PROGESTERONE 6X IRREGULAR MENSES

    SULFUR 6C DETOXIFICATION


  • USES

    Temporary relief of symptoms due to Premenstrual Syndrome such as:

    • Moodiness
    • Cramping
    • Backache
  • PREGNANCY

    If pregnant or breast-feeding ask a doctor before use

  • WARNINGS

    Stop use and ask doctor if symptoms persist more than 5 days.
    If pregnant or breast-feeding 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.
    Contains ethyl alcohol 30%

  • DIRECTIONS

    Adults: 20 drops in a little water, 2 times per day.

  • QUESTIONS

    Questions?: info@gunainc.com, tel. (484) 223-3500

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Take 15 minutes before meals

  • INACTIVE INGREDIENT

    Inactive ingredient: Ethyal alcohol 30%.

  • PRINCIPAL DISPLAY PANEL

    5USPMS-Rev04-03-07-18

  • INGREDIENTS AND APPEARANCE
    GUNA-PMS 
    arsenic trioxide - estradiol - goldenseal - lachesis muta venom - magnesium phosphate - matricaria recutita - melatonin - progesterone - strychnos nux-vomica seed - sulfur - sus scrofa ovary - sus scrofa pituitary gland - solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-290
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_C]  in 30 mL
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL6 [hp_X]  in 30 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_C]  in 30 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM4 [hp_C]  in 30 mL
    MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE (UNII: 453COF7817) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE6 [hp_C]  in 30 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 30 mL
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN4 [hp_C]  in 30 mL
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE6 [hp_X]  in 30 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_C]  in 30 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_C]  in 30 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY8 [hp_X]  in 30 mL
    SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND8 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 9 mL  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-290-181 in 1 BOX12/21/2018
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/23/2006
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-290)
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