RESCUE SLEEP- helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum, and aesculus hippocastanum flower capsule, liquid filled

Rescue Sleep by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients Each 5X (HPUS)	Purpose
Helianthemum nummularium	Courage and presence of mind
Clematis vitalba	Focus when ungrounded
Impatiens glandulifera	Patience with problems and people
Prunus cerasifera	Balanced mind when losing control
Ornithogalum umbellatum	Softens impact of shock
Aesculus hippocastanum	Relief from repetitive thoughts

Uses

• Provides natural relief of occasional sleeplessness caused by stress and repetitive thoughts.

Warnings

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children

PREGNANCY OR BREAST FEEDING

• If pregnant or breast–feeding, ask a health professional before use

DO NOT USE

• Do not use if the tamper evident seal is broken

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

Directions

• Adults and children over 12, place 1 capsule on tongue and let dissolve prior to retiring. Additional capsules may be taken as needed.

Other Information

• Store below 77°F (25°C)
• No artificial colors or artificial fragrances
• Active ingredients made according to the Homeopathic Pharmacopoeia of the United States (HPUS)

Inactive Ingredients

Carnauba wax, coconut oil, gelatin (fish), grapeseed oil, natural orange flavor, natural vanilla flavor, pectin, sorbitol.

Questions?

1-800-319-9151

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Distributed by Nelsons, North Andover, MA 01845

PRINCIPAL DISPLAY PANEL - 28 Capsule Blister Pack Carton

RESCUE

NDC #57687-291-28

Bach®
ORIGINAL
FLOWER REMEDIES

28 CAPSULES

RESCUE®
SLEEP*
LIQUID
MELTS

NATURAL SLEEP AID
IN A CAPSULE

DISSOLVABLE

NON–HABIT
FORMING

ALCOHOL–FREE

28 Capsules

HOMEOPATHIC
*See back panel

INGREDIENTS AND APPEARANCE

RESCUE SLEEP 
helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum, and aesculus hippocastanum flower capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57687-291
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]
Clematis vitalba flower (UNII: 7SCP4N87CI) (Clematis vitalba flower - UNII:7SCP4N87CI)	Clematis vitalba flower	5 [hp_X]
Impatiens glandulifera flower (UNII: AJU5O1A5ZV) (Impatiens glandulifera flower - UNII:AJU5O1A5ZV)	Impatiens glandulifera flower	5 [hp_X]
Prunus cerasifera flower (UNII: 0KD7R09EAS) (Prunus cerasifera flower - UNII:0KD7R09EAS)	Prunus cerasifera flower	5 [hp_X]
Ornithogalum umbellatum (UNII: 9NS3M2Y78S) (Ornithogalum umbellatum - UNII:9NS3M2Y78S)	Ornithogalum umbellatum	5 [hp_X]
Aesculus hippocastanum flower (UNII: KK0Z92II8M) (Aesculus hippocastanum flower - UNII:KK0Z92II8M)	Aesculus hippocastanum flower	5 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
carnauba wax (UNII: R12CBM0EIZ)
coconut oil (UNII: Q9L0O73W7L)
MARINE NON-GELLING GELATIN, HIGH MW (UNII: AHQ60JKI5D)
grape seed oil (UNII: 930MLC8XGG)
ORANGE OIL (UNII: AKN3KSD11B)
VANILLA (UNII: Q74T35078H)
pectin (UNII: 89NA02M4RX)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE (sphere)	Size	5mm
Flavor	ORANGE, VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57687-291-28	2 in 1 CARTON	02/24/2010
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		02/24/2010

Labeler - Nelson Bach USA, Ltd. (877720193)

Registrant - A Nelson & Co Limited (221471234)

Establishment
Name	Address	ID/FEI	Business Operations
A. Nelson & Co. Limited		221471234	PACK(57687-291) , LABEL(57687-291) , ANALYSIS(57687-291)