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
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:
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).