MedPath
FDA Approval

Sunshine MenopauseRelief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Apcco Labs, Inc
DUNS: 041378961
Effective Date
June 18, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Arnica montana(2 [hp_X] in 1 mg)
Black cohosh(2 [hp_X] in 1 mg)
chaste tree fruit oil(2 [hp_X] in 1 mg)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Apcco Labs, Inc

Apcco Labs, Inc

041378961

Products1

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

Sunshine MenopauseRelief

Product Details

NDC Product Code
82126-002
Route of Administration
VAGINAL
Effective Date
June 18, 2025
Code: O80TY208ZWClass: ACTIBQuantity: 2 [hp_X] in 1 mg
HYDROGENATED PALM OILInactive
Code: 257THB963HClass: IACT
Code: K73E24S6X9Class: ACTIBQuantity: 2 [hp_X] in 1 mg
.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
chaste tree fruit oilActive
Code: G7W43U4YTFClass: ACTIBQuantity: 2 [hp_X] in 1 mg
ALOE VERA LEAFInactive
Code: ZY81Z83H0XClass: IACT
ASCORBYL TETRAISOPALMITATEInactive
Code: 47143LT58AClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL DISPLAY:

LabelLabel Meno


INDICATIONS & USAGE SECTION

INDICATIONS:

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

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

DOSAGE & ADMINISTRATION SECTION

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.


WARNINGS SECTION

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 - ACTIVE INGREDIENT SECTION

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

PURPOSE:

Anti-hot flashes and mood swings

Supports physical and emotional stability

Hormone-balancing

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN:

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

OTC - QUESTIONS SECTION

QUESTIONS:

Call 844-995-5856

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding...

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


SPL UNCLASSIFIED SECTION

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.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Hydrogenated

Hydroxypropyl

Methylcellulose,

Aloe Vera.

Tetrahexyldecyl Ascorbate (Vitamin C),

Alpha-Tocopherol (Vitamin E).


© Copyright 2025. All Rights Reserved by MedPath