Label: MENOPAUSE RELIEF- amyl nitrosum, calcarea carbonica, caulophyllum thalictroides, cimicifuga racemosa, ferrum metallicum, gelsemium sempervirens, lachesis mutus, pulsatilla, sanguinaria canadensis, sepia, sulphur, sulphuricum acidum. liquid
- NDC Code(s): 57955-7006-2
- Packager: King Bio Inc.
- 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 September 14, 2022
If you are a consumer or patient please visit this version.
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OTHER SAFETY INFORMATION
Other information
Tamper resistant for your protection.
Use only if safety seal is intact.
Keep carton for complete drug facts and product information.
Questions? Call 866.298.2740
King Bio, Inc. 3 Westside Drive
Asheville, NC 2806 USA
FDA Reg. #1053442
For latest product information and instructions: www.DrKings.com
Reference image: Menopause.jpg
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Inactive Ingredients
Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).
Reference image: Menopause.jpg
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Active ingredients
Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.Amyl nitrosum, Calcarea carbonica, Caulophyllum thalictroides, Cimicifuga racemosa, Ferrum metallicum, Gelsemium sempervirens, Lachesis mutus, Pulsatilla, Sanguinaria canadensis, Sepia, Sulphur, Sulphuricum acidum.
Reference image: Menopause.jpg
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Uses
For temporary relief of of discomforts associated with menopause:
hot flashes
night sweats
chills
headaches
uterine cramps
mood swings
sensitivity
irritability
fatigue
poor memory
As per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.Reference image: Menopause.jpg
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Warnings
Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.If pregnant or breast-feeding, ask a healthcare professional
before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately.
Reference image: Menopause.jpg
- KEEP OUT OF REACH OF CHILDREN
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PURPOSE
Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.Amyl nitrosum................................hot flashes, profuse sweating
Calcarea carbonica ....................headaches, night sweats, chills
Caulophyllum thalictroides .........................irritability, exhaustion
Cimicifuga racemosa........................................... uterine cramps
Ferrum metallicum ........................................................irritability
Gelsemium sempervirens ....................... inability to concentrate
Lachesis mutus ............................prefers to be alone, sensitivity
Pulsatilla.................................................... mood swings, fatigue
Sanguinaria canadensis...........................headache, hot flashes
Sepia ..........................................................hot flashes, sweating
Sulphur..................................................confusion, poor memory
Sulphuricum acidum..................neck and back pain, impatienceReference image: Menopause.jpg
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MENOPAUSE RELIEF
amyl nitrosum, calcarea carbonica, caulophyllum thalictroides, cimicifuga racemosa, ferrum metallicum, gelsemium sempervirens, lachesis mutus, pulsatilla, sanguinaria canadensis, sepia, sulphur, sulphuricum acidum. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-7006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMYL NITRITE (UNII: 22T8Z09XAK) (AMYL NITRITE - UNII:22T8Z09XAK) AMYL NITRITE 10 [hp_X] in 59 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 59 mL CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT 10 [hp_X] in 59 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 10 [hp_X] in 59 mL IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 10 [hp_X] in 59 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 10 [hp_X] in 59 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 10 [hp_X] in 59 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 10 [hp_X] in 59 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 10 [hp_X] in 59 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_X] in 59 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 59 mL SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) ORANGE PEEL (UNII: TI9T76XD44) CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY) CARYA OVATA BARK (UNII: X765CF609L) STEVIOL (UNII: 4741LYX6RT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-7006-2 1 in 1 CARTON 06/12/2022 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/12/2022 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-7006) , api manufacture(57955-7006)
