sleep 5 [hp_X]/29.6mL
Aesculus hippocastanum, flos, Ferrum Phos, Kali Carb, Kali Phos, Mag Phos, Nat Mur, Populus termula, flos, Prunus cerasifera, flos · SPRAY · Siddha Flower Essences LLC
Sleep is an over-the-counter oral spray containing a combination of herbal and mineral ingredients traditionally used to support sleep. This product is not classified under a specific drug class and is formulated as a homeopathic remedy.
Key Facts
- Brand Name
- sleep
- Generic Name
- Aesculus hippocastanum, flos, Ferrum Phos, Kali Carb, Kali Phos, Mag Phos, Nat Mur, Populus termula, flos, Prunus cerasifera, flos
- NDC Code (Product)
69779-012- Manufacturer
- Siddha Flower Essences LLC
- Strength
- 5 [hp_X]/29.6mL
- Dosage Form
- SPRAY
- Route
- ORAL
- Marketing Status
- Marketing Start
- 04/09/2015
Recall History
Chattem Inc
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Ultra Seal Corporation
cGMP deviations
LNK International, Inc.
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
LNK International, Inc.
Microbial contamination of non-sterile product
Ultra Seal Corporation
cGMP deviations
King Bio Inc.
Microbial contamination
Ultra Seal Corporation
cGMP deviations
King Bio Inc.
Microbial contamination
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Ultra Seal Corporation
cGMP deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use for relief of occasional sleeplessness caused by stress and repetitive thoughts
Dosage & Administration
Directions adults: apply 2 sprays onto the tongue. Additional sprays may be taken during the night as needed. children under 12: ask a doctor
Warnings
Warnings When using this product keep away from eyes Stop use and ask a doctor if sleeplessness persists for more than two weeks: insomnia can be a symptom of serious underlying medical illness If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Frequently Asked Questions
What is sleep used for?
Sleep is an over-the-counter oral spray containing a combination of herbal and mineral ingredients traditionally used to support sleep. This product is not classified under a specific drug class and is formulated as a homeopathic remedy.
Is sleep a controlled substance?
sleep is not classified as a controlled substance by the DEA.
What is the generic name for sleep?
The generic name for sleep is Aesculus hippocastanum, flos, Ferrum Phos, Kali Carb, Kali Phos, Mag Phos, Nat Mur, Populus termula, flos, Prunus cerasifera, flos. There are no other listed brand versions of Aesculus hippocastanum, flos, Ferrum Phos, Kali Carb, Kali Phos, Mag Phos, Nat Mur, Populus termula, flos, Prunus cerasifera, flos.
What is the NDC code for sleep 5 [hp_X]/29.6mL?
The NDC (National Drug Code) for sleep 5 [hp_X]/29.6mL is 69779-012, listed by Siddha Flower Essences LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)