Drug Facts

Drug Facts

SPL v10

SPL

SPL Set ID 0f99bbef-6239-41cd-96ac-312a79627efd

Route

ORAL

Published

Effective Date 2015-09-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Apis Mellifera (10 [hp_X]) Chamomile Black Cohosh Cyclamen Purpurascens Tuber Chamaelirium Luteum Root Strychnos Ignatii Seed Canis Lupus Familiaris Milk Lycopodium Clavatum Spore Sodium Cation Strychnos Nux-vomica Seed Platinum Sepia Officinalis Juice

Inactive Ingredients

Water Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2011-02-21

Description

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

Medication Information

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

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

Uses

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

exhaustion
dullness
drowsiness
muscle weakness

Section 50565-1

Keep out of the reach of children.

Section 50566-9

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

Section 50567-7

When using this product use only as directed.

Section 53414-9

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

Warnings

Ask a doctor before use if

you are taking any other medications
you have a medical condition

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.

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

Recommended Dosage

1 mL twice per day

-or as needed*

*Excessive dosing may cause mild digestive discomfort.

Inactive Ingredients

citric acid, potassium sorbate, purified ionized mineral water.

Questions Or Comments?

You can email us at [email protected] or call us toll-free at 1.800.875.0850 Monday through Friday, 9am-5pm ET.

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

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.

Structured Label Content

Uses

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

exhaustion
dullness
drowsiness
muscle weakness

Description (34089-3)

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

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product use only as directed.

Section 53414-9 (53414-9)

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

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

Warnings

Ask a doctor before use if

you are taking any other medications
you have a medical condition

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.

Other Information (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

Recommended Dosage (RECOMMENDED DOSAGE)

1 mL twice per day

-or as needed*

*Excessive dosing may cause mild digestive discomfort.

Inactive Ingredients

citric acid, potassium sorbate, purified ionized mineral water.

Questions Or Comments? (Questions or comments?)

You can email us at [email protected] or call us toll-free at 1.800.875.0850 Monday through Friday, 9am-5pm ET.

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

Active Ingredients (per Dose) (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.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "APIS MELLIFERA", "unii": "7S82P3R43Z", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "BLACK COHOSH", "unii": "K73E24S6X9", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CYCLAMEN PURPURASCENS TUBER", "unii": "G728143D8Q", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CHAMAELIRIUM LUTEUM ROOT", "unii": "DQV54Y5H3U", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS IGNATII SEED", "unii": "1NM3M2487K", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CANIS LUPUS FAMILIARIS MILK", "unii": "G39P120JQT", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "LYCOPODIUM CLAVATUM SPORE", "unii": "C88X29Y479", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CATION", "unii": "LYR4M0NH37", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "unii": "269XH13919", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PLATINUM", "unii": "49DFR088MY", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SEPIA OFFICINALIS JUICE", "unii": "QDL83WN8C2", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": " to temporarily relieve symptoms commonly associated with PMS, such as: exhaustion dullness drowsiness muscle weakness", "34089-3": "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", "50565-1": "Keep out of the reach of children.", "50566-9": "Stop use and ask a doctor if symptoms persist or worsen.", "50567-7": "When using this product use only as directed.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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", "Warnings": "Ask a doctor before use if you are taking any other medications you have a medical condition", "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.", "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", "RECOMMENDED DOSAGE": " 1 mL twice per day -or as needed* *Excessive dosing may cause mild digestive discomfort.", "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.", "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", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:48.990195 · Updated: 2026-03-14T23:14:47.176757