Label: PEACEFULI- avena sativa, humulus lupulus, passiflora incarnata, kali phosphoricum, anacardium orientale, argentum nitricum, ignatia amara spray
- NDC Code(s): 71753-4001-1
- Packager: Ratis, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 May 25, 2023
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- ACTIVE INGREDIENT:
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PURPOSE:
Avena Sativa – nervousness, sleeplessness,* Humulus Lupulus – overexcitement, tension,* Passiflora Incarnata – worries, insomnia,* Kali Phosphoricum – overwork, fatigue,* Phosphoricum Acidum – mental exhaustion,* Anacardium Orientale – doubt, apprehension, * Argentum Nitricum – fear, anxiousness,* Ignatia Amara – hypersensitivity, grief.*
- USES:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
PEACEFULI
avena sativa, humulus lupulus, passiflora incarnata, kali phosphoricum, anacardium orientale, argentum nitricum, ignatia amara sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71753-4001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 3 [hp_X] in 1 mL HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 3 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE 6 [hp_X] in 1 mL PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 6 [hp_X] in 1 mL SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 6 [hp_C] in 1 mL SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 6 [hp_C] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 6 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71753-4001-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/23/2020 Labeler - Ratis, LLC (964594324)