Label: HENDEL INSOMNIA RELIEF- passiflora incarnata flowering top, ambergris, scutellaria lateriflora, zinc valerate dihydrate, anamirta cocculus seed, and arabica coffee bean tablet
- NDC Code(s): 62795-1120-2
- Packager: MediNatura Inc
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 16, 2023
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WARNINGS
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if sensitivity to Insomnia Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Directions
- KEEP OUT OF REACH OF CHILDREN
- Uses
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HENDEL INSOMNIA RELIEF
passiflora incarnata flowering top, ambergris, scutellaria lateriflora, zinc valerate dihydrate, anamirta cocculus seed, and arabica coffee bean tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-1120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X] AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS 6 [hp_X] SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA 6 [hp_X] ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE 6 [hp_X] ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 12 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 12 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code leafman Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62795-1120-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/31/2016 Labeler - MediNatura Inc (079324099) Establishment Name Address ID/FEI Business Operations MediNatura Inc 102783016 manufacture(62795-1120)