Sleep

Sleep

Drug Labeling and Warnings

Drug Details

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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Sleep

Drug Facts

Active ingredientsPurpose
"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 HPUSwakefulness, 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

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
SLEEP 
hyoscyamus niger, strychnos ignatii seed, and potassium phosphate, dibasic tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54973-3206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER6 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_X]
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54973-3206-11 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC11/05/2014
Labeler - Hyland's (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655MANUFACTURE(54973-3206) , PACK(54973-3206)

Revised: 9/2014
 
Hyland's


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