MedPath

Sunshine MenopauseRelief

Apcco Labs, MenopauseRelief

Approved
Approval ID

37de2698-c6ae-ab67-e063-6394a90ab248

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 18, 2025

Manufacturers
FDA

Apcco Labs, Inc

DUNS: 041378961

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Menopause Suppository

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82126-002
Product Classification
G
Generic Name
Menopause Suppository
Product Specifications
Route of AdministrationVAGINAL
Effective DateJune 18, 2025
FDA Product Classification

INGREDIENTS (8)

ARNICA MONTANAActive
Quantity: 2 [hp_X] in 1 mg
Code: O80TY208ZW
Classification: ACTIB
HYDROGENATED PALM OILInactive
Code: 257THB963H
Classification: IACT
BLACK COHOSHActive
Quantity: 2 [hp_X] in 1 mg
Code: K73E24S6X9
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CHASTE TREE FRUIT OILActive
Quantity: 2 [hp_X] in 1 mg
Code: G7W43U4YTF
Classification: ACTIB
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
ASCORBYL TETRAISOPALMITATEInactive
Code: 47143LT58A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/25/2016

PACKAGE LABEL DISPLAY:

LabelLabel Meno

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/25/2016

INDICATIONS:

Temporarily relieves symptoms associated with menopause, such as hot flashes, night sweats,

mood swings, occasional sleeplessness, hormonal imbalance, and mild fatigue.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/25/2016

ACTIVE INGREDIENTS:

Black Cohosh 2X HPUS* ... Anti-hot flashes and mood swings

Arnica montana 2X HPUS*......Supports physical and emotional stability

Chasteberry Oil 2X HPUS*|..... Hormone-balancing

*"HPUS" indicates the active ingredients are in the official Homeopathic

Pharmacopeia of the United States.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/25/2016

PURPOSE:

Anti-hot flashes and mood swings

Supports physical and emotional stability

Hormone-balancing

WARNINGS SECTION

LOINC: 34071-1Updated: 8/25/2016

WARNINGS:

Warnings

For vaginal use only. Not for oral consumption.

Do not useIf you are allergic to any of the ingredients.

When using this productdo not exceed the recommended dose.

Ask a doctor before use

If you have irregular menstrual cycles not related to menopause • If you are taking hormone replacement therapy (HRT) or other medications

Stop use and ask a doctor

If symptoms persist for more than 7 days or worsen
If new symptoms occur
If you experience an allergic reaction

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 8/25/2016

If pregnant or breast feeding...

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/25/2016

KEEP OUT OF REACH OF CHILDREN:

If swallowed, get medical help or contact a poison control center immediately at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/25/2016

DIRECTIONS:

Women 45 years of age and over:

Insert one suppository vaginally once daily, preferably at bedtime or as directed by a healthcare provider. For best results, use consistently during the menopausal transition or when symptoms are present.

Not for use in children or women under 45 years of age unless directed by a healthcare provider.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/25/2016

INACTIVE INGREDIENTS:

Hydrogenated

Hydroxypropyl

Methylcellulose,

Aloe Vera.

Tetrahexyldecyl Ascorbate (Vitamin C),

Alpha-Tocopherol (Vitamin E).

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/25/2016

OTHER INFORMATION:

Store in a cool and dry place away from direct sunlight.
Do not use it if the suppository seal is broken or missing.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/25/2016

QUESTIONS:

Call 844-995-5856

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Sunshine MenopauseRelief - FDA Drug Approval Details