SPL v2
SPL
SPL Set ID ae63fe31-f602-4171-abed-a7212864d064
Route
ORAL
Published
Effective Date 2024-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hippophae Rhamnoides Whole (380 mg) Lepidium Meyenii Root (120 mg) Eurycoma Longifolia Root (20 mg)
Inactive Ingredients
Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: yellow Size: 23 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-08-19

Description

 Dietary supplement


Medication Information

Warnings and Precautions

Other Ingredients

Maltodextrin, Magnesium Stearate

Description

 Dietary supplement

Section 42232-9

If you are pregnant, may become pregnant or are breast feeding, consult your healthcare professional before using this product. Do not use if tamper-evident seal is broken or missing.

Keep Out of The Reach of Children.

Store in a cool, dry place (59oF-86oF), avoid moisture and light.

Section 55106-9

Section 69719-3

Identity

 Dietary supplement

Direction

Take 4 capsules per day with or after a meal, two in the morning and two in the evening.

Product Label

Safe Handling Warning 

Omelia TM

Clinically Proven Omega 7 and 3-6-9 Promote Skin, Eyes, and Vaginal Health*

Omelia TM is supplementing with functional dosage formula:

- Sea Buckthorn from Tibet provides clinically proven plant-based Omega 3-6-7-9, promoting inner beauty and supporting women’s health.*

- Peruvian Maca root enhances sexual vitality and alleviates mood swings in postmenopausal women.*

- Tongkat Ali from Malaysia naturally enhances libido, uplifts mood, and offers stress relief support.*

* These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.


Structured Label Content

Warnings and Precautions (34071-1)

Other Ingredients

Maltodextrin, Magnesium Stearate

Section 42232-9 (42232-9)

If you are pregnant, may become pregnant or are breast feeding, consult your healthcare professional before using this product. Do not use if tamper-evident seal is broken or missing.

Keep Out of The Reach of Children.

Store in a cool, dry place (59oF-86oF), avoid moisture and light.

Section 55106-9 (55106-9)

Section 69719-3 (69719-3)

Identity

 Dietary supplement

Direction

Take 4 capsules per day with or after a meal, two in the morning and two in the evening.

Product Label (Product label)

Safe Handling Warning  (Safe handling warning )

Omelia TM

Clinically Proven Omega 7 and 3-6-9 Promote Skin, Eyes, and Vaginal Health*

Omelia TM is supplementing with functional dosage formula:

- Sea Buckthorn from Tibet provides clinically proven plant-based Omega 3-6-7-9, promoting inner beauty and supporting women’s health.*

- Peruvian Maca root enhances sexual vitality and alleviates mood swings in postmenopausal women.*

- Tongkat Ali from Malaysia naturally enhances libido, uplifts mood, and offers stress relief support.*

* These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.


Advanced Ingredient Data


Raw Label Data

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