Menopause
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-03-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:00
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Menopause Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.
DOSAGE & ADMINISTRATION SECTION
Directions: Adults, take 6 pellets orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Elaps corallinus 30x, Agnus 10x, Angelica sinensis radix 10x, Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Caulophyllum 10x, Cimicifuga 10x, Cinchona 10x, Crotalus horridus 10x, Damiana 10x, Glonoinum 10x, Helonias dioica 10x, Ignatia 10x, Kali carb. 10x, Lachesis 10x, Naja 10x, Nux vom.10x, Phosphorus 10x, Pulsatilla 10x, Salix nigra 10x, Sanguinaria 10x, Sepia 10x, Echinacea 3x, Valeriana 3x.
OTC - PURPOSE SECTION
Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7480e90b-004b-ebe4-2243-4f2fefdd9e78 | Product name | 2 | 20260128 |
| 3f158398-73f2-4b90-47d1-5c60e8719a98 | Product name | 9 | 20250721 |
| ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0 | Product name | 2 | 20250117 |
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 00358076-c817-430b-b924-11d717dc307c | Product name | 1 | 20160718 |
| 669af5aa-14f3-3df7-f100-5f580ffd43c1 | Product name | 1 | 20140508 |
| 6ff3bab7-2dce-8bea-d7ce-54687f0c01fb | Product name | 1 | 20140508 |
| 8bb82a1c-d0d0-fc27-011f-172e545f0382 | Product name | 1 | 20140508 |
| cb03406d-e223-80bb-67d8-be80f9b6a4f2 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-2235-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5737-f424-e053-dadaa90a57ce | Menopause |
| 55714-2235-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5737-f424-e053-dadaa90a57ce | Menopause |
| 55714-2235-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5737-f424-e053-dadaa90a57ce | Menopause |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2235-0 | Menopause | 7.08 g in 1 BOTTLE, GLASS | PELLET | 7.08 | 2 | |
| 55714-2235-1 | Menopause | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 2 | |
| 55714-2235-2 | Menopause | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2235 | MENOPAUSE (ELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANA) PELLET [NEWTON LABORATORIES, INC.] | 2 | Legacy NDC, 3 package rows | 20131015_9f04d505-7475-ef8a-57ab-eb820fb49726.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Angelica Sinensis Root | ACTIVE INGREDIENT | B66F4574UG | 2 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 2 | |
| Black Cohosh | ACTIVE INGREDIENT | K73E24S6X9 | 2 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 2 | |
| Caulophyllum Thalictroides Root | ACTIVE INGREDIENT | JTJ6HH6YEH | 2 | |
| Chamaelirium Luteum Root | ACTIVE INGREDIENT | DQV54Y5H3U | 2 | |
| Chaste Tree | ACTIVE INGREDIENT | 433OSF3U8A | 2 | |
| Cinchona Officinalis Bark | ACTIVE INGREDIENT | S003A158SB | 2 | |
| Crotalus Horridus Horridus Venom | ACTIVE INGREDIENT | YHA2XLJ956 | 2 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 2 | |
| Lachesis Muta Venom | ACTIVE INGREDIENT | VSW71SS07I | 2 | |
| Lytta Vesicatoria | ACTIVE INGREDIENT | 3Q034RO3BT | 2 | |
| Micrurus Corallinus Venom | ACTIVE INGREDIENT | V0S6H36980 | 2 | |
| Naja Naja Venom | ACTIVE INGREDIENT | ZZ4AG7L7VM | 2 | |
| Nitroglycerin | ACTIVE INGREDIENT | G59M7S0WS3 | 2 | |
| Phosphorus | ACTIVE INGREDIENT | 27YLU75U4W | 2 | |
| Potassium Carbonate | ACTIVE INGREDIENT | BQN1B9B9HA | 2 | |
| Pulsatilla Vulgaris | ACTIVE INGREDIENT | I76KB35JEV | 2 | |
| Salix Nigra Bark | ACTIVE INGREDIENT | QU52J3A5B3 | 2 | |
| Sanguinaria Canadensis Root | ACTIVE INGREDIENT | N9288CD508 | 2 | |
| Sepia Officinalis Juice | ACTIVE INGREDIENT | QDL83WN8C2 | 2 | |
| Strychnos Ignatii Seed | ACTIVE INGREDIENT | 1NM3M2487K | 2 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 2 | |
| Turnera Diffusa Leafy Twig | ACTIVE INGREDIENT | RQ2CFA7WWJ | 2 | |
| Valerian | ACTIVE INGREDIENT | JWF5YAW3QW | 2 | |
| Angelica Sinensis Root | ACTIVE MOIETY | B66F4574UG | 2 | |
| Arsenic Cation (3+) | ACTIVE MOIETY | C96613F5AV | 2 | |
| Black Cohosh | ACTIVE MOIETY | K73E24S6X9 | 2 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 2 | |
| Carbonate Ion | ACTIVE MOIETY | 7UJQ5OPE7D | 2 | |
| Caulophyllum Thalictroides Root | ACTIVE MOIETY | JTJ6HH6YEH | 2 | |
| Chamaelirium Luteum Root | ACTIVE MOIETY | DQV54Y5H3U | 2 | |
| Chaste Tree | ACTIVE MOIETY | 433OSF3U8A | 2 | |
| Cinchona Officinalis Bark | ACTIVE MOIETY | S003A158SB | 2 | |
| Crotalus Horridus Horridus Venom | ACTIVE MOIETY | YHA2XLJ956 | 2 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 2 | |
| Lachesis Muta Venom | ACTIVE MOIETY | VSW71SS07I | 2 | |
| Lytta Vesicatoria | ACTIVE MOIETY | 3Q034RO3BT | 2 | |
| Micrurus Corallinus Venom | ACTIVE MOIETY | V0S6H36980 | 2 | |
| Naja Naja Venom | ACTIVE MOIETY | ZZ4AG7L7VM | 2 | |
| Nitroglycerin | ACTIVE MOIETY | G59M7S0WS3 | 2 | |
| Phosphorus | ACTIVE MOIETY | 27YLU75U4W | 2 | |
| Pulsatilla Vulgaris | ACTIVE MOIETY | I76KB35JEV | 2 | |
| Salix Nigra Bark | ACTIVE MOIETY | QU52J3A5B3 | 2 | |
| Sanguinaria Canadensis Root | ACTIVE MOIETY | N9288CD508 | 2 | |
| Sepia Officinalis Juice | ACTIVE MOIETY | QDL83WN8C2 | 2 | |
| Strychnos Ignatii Seed | ACTIVE MOIETY | 1NM3M2487K | 2 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 2 | |
| Turnera Diffusa Leafy Twig | ACTIVE MOIETY | RQ2CFA7WWJ | 2 | |
| Valerian | ACTIVE MOIETY | JWF5YAW3QW | 2 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 2 |
Products#
Every source-derived product name is available through these pages.
- Menopause
- Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana
- Micrurus Corallinus Venom
- Chaste Tree
- Angelica Sinensis Root
- Arsenic Trioxide
- Arsenic Cation (3+)
- Bryonia Alba Root
- Lytta Vesicatoria
- Caulophyllum Thalictroides Root
- Black Cohosh
- Cinchona Officinalis Bark
- Crotalus Horridus Horridus Venom
- Turnera Diffusa Leafy Twig
- Nitroglycerin
- Chamaelirium Luteum Root
- Strychnos Ignatii Seed
- Potassium Carbonate
- Carbonate Ion
- Lachesis Muta Venom
- Naja Naja Venom
- Strychnos Nux-vomica Seed
- Phosphorus
- Pulsatilla Vulgaris
- Salix Nigra Bark
- Sanguinaria Canadensis Root
- Sepia Officinalis Juice
- Echinacea, Unspecified
- Valerian
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2235 | 55714-2235-1, 55714-2235-2, 55714-2235-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f26cd39b-1c0a-f6cd-1250-169ab3e7654f | 9f04d505-7475-ef8a-57ab-eb820fb49726 | 2011-03-01 | Warnings | f26cd39b-1c0a-f6cd-1250-169ab3e7654f 9f04d505-7475-ef8a-57ab-eb820fb49726 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
