RESCUE SLEEP DROPPER- helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum whole, and aesculus hippocastanum flower solution

Rescue Sleep by

Drug Labeling and Warnings

Rescue Sleep by is a Homeopathic medication manufactured, distributed, or labeled by Nelson Bach USA Limited, A. Nelson & Co. Limited, A. Nelson & Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Warnings

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 breast-feeding, ask a health professional before use.

Keep out of reach of children.

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 INGREDIENT

glycerin [vegetable], purified water

QUESTIONS

Call 1-800-319-9151

Mon-Fri 8am-5pm (EST)

PRINCIPAL DISPLAY PANEL

Rescue Sleep Dropper

INGREDIENTS AND APPEARANCE

RESCUE SLEEP  DROPPER
helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum whole, and aesculus hippocastanum flower solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57687-243
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP)	HELIANTHEMUM NUMMULARIUM FLOWER	5 [hp_X]  in 0.095 mL
CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI)	CLEMATIS VITALBA FLOWER	5 [hp_X]  in 0.095 mL
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	5 [hp_X]  in 0.095 mL
PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS)	PRUNUS CERASIFERA FLOWER	5 [hp_X]  in 0.095 mL
ORNITHOGALUM UMBELLATUM WHOLE (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM WHOLE - UNII:9NS3M2Y78S)	ORNITHOGALUM UMBELLATUM WHOLE	5 [hp_X]  in 0.095 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	5 [hp_X]  in 0.095 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57687-243-20	1 in 1 CARTON	12/01/2020
1		20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2020

Labeler - Nelson Bach USA Limited (877720193)

Registrant - A. Nelson & Co. Limited (221471234)

Establishment
Name	Address	ID/FEI	Business Operations
A. Nelson & Co Ltd		221471234	manufacture(57687-243) , pack(57687-243) , label(57687-243) , analysis(57687-243)