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

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.

----------

Hyland's Sleep

Relieves Occasional Sleeplessness Due to Nervousness or Worry

Drug Facts

Active ingredientsPurpose

Hyoscyamus Niger 6X HPUS

(0.0000001% Alkaloids, calculated)

occasional sleeplessness

Ignatia Amara 6X HPUS

(0.0000017% Alkaloids, calculated)

anxiousness, worry
Kali Phosphoricum 3X HPUSwakefulness, occasional sleeplessness, nervousness

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

■ Temporarily relieves symptoms of occasional sleeplessness due to:
■ anxiousness ■ worry
■ wakefulness ■ nervousness

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Do not use more than directed.

Stop use and consult a physician if symptoms persist for more than 7 days or worsen.

Keep this and all medications out of the reach of children.

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Drug Facts (continued)

Directions

Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary.

Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.

Other information

Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

HOMEOPATHIC

NDC 54973-3206-1

SINCE 1903

Hyland's

Sleep*

NATURAL ACTIVE INGREDIENTS
GENTLE ON YOU

Relieves Occasional
Sleeplessness Due
to Nervousness
or Worry

100 QUICK-DISSOLVING TABLETS

* SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

NATURAL RELIEF

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 CARTON11/05/2014
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 Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3206) , pack(54973-3206)

Revised: 12/2022
Document Id: efce1ee2-5859-4587-e053-2995a90a3bba
Set id: 8ad9775f-367c-45c9-890d-69a3734965f1
Version: 4
Effective Time: 20221214
 
Hyland's Inc.