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Drug Facts
Dist. by Nelson Bach USA, Ltd.
21 High St., #302, North Andover, MA 01845
Rescue Sleep Solution
FDA Label NDC 57687-243
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nelson Bach Usa Limited for the product Rescue Sleep (NDC 57687-243). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients Each 5× (HPUS) | Purpose |
|---|---|
| White Chestnut (Aesculus hippocastanum) | Relief from repetitive thoughts |
| Rock Rose (Helianthemum nummularium) | Courage and presence of mind |
| Clematis (Clematis vitalba) | Focus when ungrounded |
| Impatiens (Impatiens glandulifera) | Patience with problems and people |
| Cherry Plum (Prunus cerasifera) | Balanced mind when losing control |
| Star of Bethlehem (Ornithogalum umbellatum) | Softens impact of shock |
Use
- for relief of occasional sleeplessness caused by stress and repetitive thoughts
Otc - When Using
When using this product keep away from eyes
Otc - Stop Use
Stop use and ask a doctor if sleeplessness persists for more than two weeks: insomnia can be a symptom of serious underlying medical illness
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children age 2 and up: take 4 drops directly on the tongue or 4 drops in water and sip at intervals. Additional drops may be taken during the night as needed.
- children under 2: ask a doctor
Other Information
- store below 77°F (25°C)
- do not use if tamper evident seal is broken
- active ingredients made according to the Homeopathic Pharmacopoeia of the United States (HPUS)
Inactive Ingredients
glycerin, purified water
Questions?
Call 1-800-319-9151
Mon-Fri 8am-5pm (EST)
Principal Display Panel - 20 Ml Bottle Carton
RESCUE
NDC #57687-243-20
Bach®
ORIGINAL
FLOWER REMEDIES
NEW
RESCUE
SLEEP®*
DROPPER
NATURAL
SLEEP
AID†
ALCOHOL-FREE
NON-HABIT
FORMING
0.7 fl oz
(20mL)
DROPPER
*See disclaimer
on back panel
Homeopathic
Principal Display Panel (20 mL Bottle Carton)
* Please review the disclaimer below.
