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sleepBeginner6 IngredientsBotanical Extract

Sleep Support Gummy

Compliant with FDA 21 CFR 101.36 Labeling Rules
FDA Label Layout PreviewStandard Vertical

Supplement Facts

Serving Size 1 Softgel
Servings Per Container 60
Amount Per Serving
%DV
Vitamin B6 (as P-5-P)
2 mg
118%
Magnesium (as Magnesium Glycinate)
50 mg
12%
Melatonin
5 mg
†
L-Theanine (as Suntheanine®)
200 mg
†
Chamomile Extract (flower) (Matricaria chamomilla)
100 mg
†
Lemon Balm Extract (leaf) (Melissa officinalis)
75 mg
†
* Percent Daily Values are based on a 2,000 calorie diet.
† Daily Value not established.
Other Ingredients: Rice bran oil, softgel (gelatin, glycerin), beeswax.
Contains: Soy (lecithin).
Other Ingredients: Rice bran oil, softgel (gelatin, glycerin), beeswax.
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Form Factor
Softgel
Serving Size
1 Softgel
Active Constituents
6 Total
Proprietary Blends
N/A

Applied FDA 21 CFR Compliance Rules

3 Pre-built Guardrails
✓
Melatonin Rounding Rules21 CFR 101.36(b)(3)

Under 21 CFR 101.36(b)(2)(iii), dietary ingredients present in amounts less than 10mg must be declared to the nearest tenth (e.g., 5.0mg). Amounts above 10mg are rounded to the nearest whole integer.

✓
Botanical Extract Formatting21 CFR 101.4(h)

Plant-based ingredients like Chamomile (Matricaria chamomilla) must list the part of the plant used (e.g., flower) and follow standardized source declarations per 21 CFR 101.4(h).

✓
No Established DV Declaration21 CFR 101.36(b)(2)

Non-essential nutrients like L-Theanine and Melatonin must be grouped in the lower section of the panel with a cross (†) indicating Daily Value not established.

Key Ingredients in This Formula

2 ReferencedBrowse all 15 →
MagnesiumMinerals

Essential mineral involved in 300+ enzymatic reactions. FDA RDI for adults 4+ is 420 mg per day. Common forms include glycinate, citrate, and oxide.

MelatoninOther Ingredients

Hormone regulating sleep-wake cycles. No FDA-established RDI; declared as "† Daily Value not established" on Supplement Facts labels.

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FDA Label Formatting Guide for Sleep Support Gummy

Formulating a compliant sleep support gummy requires strict adherence to FDA dietary supplement labeling regulations under 21 CFR 101.36. This template demonstrates the correct formatting for popular sleep ingredients like Melatonin, L-Theanine, and botanical extracts, ensuring your Supplement Facts panel passes regulatory review without costly printing errors.

Sleep support formulas typically combine amino acids (L-Theanine), hormones (Melatonin), and botanical extracts (Chamomile, Lemon Balm). Each category has distinct FDA declaration requirements: melatonin needs mg-level rounding, botanicals require Latin binomial and plant part, and ingredients without established Daily Values must display the dagger (†) symbol with proper footnote.

Frequently Asked Questions

How to list melatonin on a supplement facts label?

Melatonin is listed as a dietary ingredient with amount per serving (e.g. 5 mg). It has no established Daily Value, so the %DV column shows "†" with footnote "Daily Value not established."

What is the FDA rounding rule for melatonin?

Per FDA 21 CFR 101.36(b)(2)(iii), melatonin amounts follow standard rounding: ≥ 10 mg rounds to nearest 1 mg, 1-10 mg rounds to nearest 0.5 mg, < 1 mg rounds to nearest 0.1 mg.

Should chamomile extract list the plant part on a label?

Yes. Per FDA 21 CFR 101.4(h), botanical ingredients must declare the plant part (e.g. "flower") and Latin binomial (e.g. "Matricaria chamomilla") in parentheses after the common name.

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