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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3), STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K), POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)
Available from:
Hyland's
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporarily relieves the symptoms of occasional nighttime sleeplessness and wakefulness due to nervousness, anxiousness, or worry.
Authorization status:
unapproved homeopathic
Authorization number:
54973-3206-1

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 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

Us es

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*

TABLETS

SLEEP

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

Product Information

Hyland's

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:549 73-320 6

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYO SCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER -

UNII:4WRK2153H3)

HYOSCYAMUS NIGER

6 [hp_X]

STRYCHNO S IGNATII SEED (UNII: 1NM3M248 7K) (STRYCHNOS IGNATII SEED -

UNII:1NM3M248 7K)

STRYCHNOS IGNATII SEED

6 [hp_X]

PO TASSIUM PHO SPHATE, DIBASIC (UNII: CI71S9 8 N1Z) (PHOSPHATE ION -

UNII:NK0 8 V8 K8 HR)

POTASSIUM PHOSPHATE,

DIBASIC

3 [hp_X]

Inactive Ingredients

Ingredient Name

Stre ng th

ACACIA (UNII: 5C540 3N26 O)

LACTO SE (UNII: J2B2A4N9 8 G)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:549 73-320 6 -

1 in 1 CARTON

11/0 5/20 14

1

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

11/0 5/20 14

Labeler -

Hyland's (028570695)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Standard Ho meo pathic Co mpany

0 0 8 316 6 55

manufacture(549 73-320 6 ) , pack(549 73-320 6 )

Revised: 11/2019

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