SLEEP- hyoscyamus niger, strychnos ignatii seed, and potassium phosphate, dibasic tablet

Sleep by

Drug Labeling and Warnings

Sleep by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids)	occasional nighttime sleeplessness
Ignatia Amara 6X HPUS (0.0000017% Alkaloids)	anxiousness, worry
Kali Phosphoricum 3X HPUS	wakefulness, occasional sleeplessness, nervousness

Uses

Temporarily relieves the symptoms of occasional nighttime sleeplessness and wakefulness due to nervousness, anxiousness, or worry.

Warnings

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years and over: Dissolve 2-3 tablets under tongue 1/2 hour to 1 hour before retiring. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue 1/2 hour to 1 hour before retiring.

Other information

• do not use if imprinted tamper band is broken or missing
• Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659

Inactive ingredients

Acacia Gum, Lactose N.F.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

NDC: 54973-3206-1

Hyland's®

HOMEOPATHIC

Sleep

Natural Relief of Occasional
Sleeplessness and Nervousness*

100
TABLETS

INGREDIENTS AND APPEARANCE

SLEEP 
hyoscyamus niger, strychnos ignatii seed, and potassium phosphate, dibasic tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3206
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	6 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	6 [hp_X]
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3206-1	1 in 1 CARTON	11/05/2014
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/05/2014

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3206) , pack(54973-3206)