Label: SAFREL MELATONIN- melatonin tablet
- NHRIC Code(s): 71309-634-60, 71309-634-90
- Packager: Safrel Pharmaceuticals, LLC.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated August 30, 2020
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- Official Label (Printer Friendly)
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STATEMENT OF IDENTITY
SUPPLEMENT FACTS Suggested Use: For adults, chew two gummies 30 minutes prior to sleep event. Gummy should be chewed before swallowing. Serving Size: 2 gummies Servings Per Container: 30 Amount per serving %Daily Value Melatonin 3mg ** ** Daily Value (DV) not established Other ingredients: croscarmellose sodium, dicalcium phosphate, microcrystalline cellulose, magnesium stearate, silicon dioxide, stearic acid
- HEALTH CLAIM
- WARNINGS
- HEALTH CLAIM
- HEALTH CLAIM
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HEALTH CLAIM
WARNING
If you are under medical supervision or using any tranquilizers or sedatives, seek the advice of your health care professional prior to using. Consult your healthcare professional before using ifyou have an autoimmune condition, depressive disorder or are pregnant or lactating. Not for use by children under 12 years of age. Do not take when operating machinery or driving a vehicle.
- PRINCIPAL DISPLAY PANEL - Vitamin Bottle Label
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INGREDIENTS AND APPEARANCE
SAFREL MELATONIN
melatonin tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:71309-634 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Melatonin (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) Melatonin 3 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:71309-634-60 60 in 1 BOTTLE 2 NHRIC:71309-634-90 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 08/30/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 4 mm scoring 1 Labeler - Safrel Pharmaceuticals, LLC. (080566287)
