Sleep: Homeopathic Product Information

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.

Relieves Occasional Sleeplessness Due to Nervousness or Worry

Drug Facts

Active ingredients Purpose

Hyoscyamus Niger 6X HPUS

(0.0000001% Alkaloids, calculated)

occasional sleeplessness

Ignatia Amara 6X HPUS

(0.0000017% Alkaloids, calculated)

anxiousness, worry
Kali Phosphoricum 3X HPUS wakefulness, 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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMUS NIGER (HYOSCYAMUS NIGER) HYOSCYAMUS NIGER 6 [hp_X]
STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 6 [hp_X]
POTASSIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) POTASSIUM PHOSPHATE, DIBASIC 3 [hp_X]
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3206-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3206-1)
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 Operations
Standard Homeopathic Company 008316655 manufacture (54973-3206), pack (54973-3206)

Revised: 04/2021 Hyland’s

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