Label: PREMENSA PMS SYMPTOM RELIEF- apis mellifica, chamomilla, cimicifuga racemosa, cyclamen europaeum, helonias dioca, ignatia amara, lac caninum, lycopodium clavatum, natrum muriaticum, nux vomica, platinum metallicum, sepia 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 26, 2018

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

View All Sections
  • Active Ingredients (per dose)

    Apis mellifica HPUS
    Chamomilla HPUS
    Cimicifuga racemosa HPUS
    Cyclamen europaeum HPUS
    Helonias dioica HPUS
    Ignatia amara HPUS
    Lac caninum HPUS
    Lycopodium clavatum HPUS
    Natrum muriaticum HPUS
    Nux vomica HPUS
    Platinum metallicum HPUS
    Sepia HPUS

    Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.  Product indications are based on Homeopathic Materia Medica.

  • Purpose

    Apis mellifica HPUS..…………………………Cramps
    Chamomilla HPUS…………………………….Sensitivity
    Cimicifuga racemosa HPUS.……………......Migraines
    Cyclamen europaeum HPUS………….….....Headaches
    Helonias dioica HPUS………………………..Pain/weakness
    Ignatia amara HPUS.…………………..……..Mood swings
    Lac caninum HPUS.…………………………..Weakness
    Lycopodium clavatum HPUS..…..……….....Excessive hunger
    Natrum muriaticum HPUS…………………....Water retention
    Nux vomica HPUS…………………………….Sensitivity
    Platinum metallicum HPUS……………….....Irritability
    Sepia HPUS……………..……………………..Hot flashes

  • Uses

     to temporarily relieve symptoms commonly associated with PMS, such as:

    • exhaustion
    • dullness
    • drowsiness
    • muscle weakness
  • Warnings

    Ask a doctor before use if

    • you are taking any other medications
    • you have a medical condition

    When using this product use only as directed.

    Stop use and ask a doctor if symptoms persist or worsen.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of the reach of children.

  • Directions

    Dispense Premensa directly into mouth, or add recommended dosage into 8-12 oz purified (non-chlorinated) water and drink. Safe for ages 2 and up.

  • RECOMMENDED DOSAGE


          1 mL twice per day
              -or as needed*

    *Excessive dosing may cause mild digestive discomfort.

  • Other information

    • do not use if tamper seal is broken
    • store in a cool, dry place
    • product must not come in contact with metal 
    • do not store next to electrical devices or appliances
  • Inactive Ingredients

    citric acid, potassium sorbate, purified ionized mineral water.

  • Questions or comments?

    You can email us at info@hellolife.net or call us toll-free at 1.800.875.0850 Monday through Friday, 9am-5pm ET.

  • DESCRIPTION

    • 30-day supply
    • dropper included
    • Premensa is made without alcohol or sugar; no gluten added.


    Mftd for: HelloLife, Inc.
    4460 44th St. SE, Ste. C-600
    Grand Rapids, MI 49512
    FDA Pharmaceutical Establishment #1053442, #3009727070
    www.premensa.com

  • Principal Display Panel

    NDC 49726-016-02

    PREMENSA®

    PMS Symptom Relief


    To temporarily relieve symptoms commonly associated with PMS, such as:

    • cramps
    • nausea
    • bloating
    • exhaustion


    2 fl. oz (59 mL)

    Homeopathic (OTC) Medicine

    PremensaCarton

  • INGREDIENTS AND APPEARANCE
    PREMENSA  PMS SYMPTOM RELIEF
    apis mellifica, chamomilla, cimicifuga racemosa, cyclamen europaeum, helonias dioca, ignatia amara, lac caninum, lycopodium clavatum, natrum muriaticum, nux vomica, platinum metallicum, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49726-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 59 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE10 [hp_X]  in 59 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 59 mL
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER10 [hp_X]  in 59 mL
    CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK10 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 59 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE10 [hp_X]  in 59 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 59 mL
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49726-016-021 in 1 CARTON02/21/2011
    159 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/21/2011
    Labeler - Hello Life, Inc. (065619378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hello Life, Inc.065619378relabel(49726-016) , repack(49726-016)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(49726-016)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!