Drug Facts

Active ingredients

Active ingredients	Purpose
Belladonna 12X HPUS	hot flashes, night sweats
Caulophyllum 12X HPUS	irritability
Cimicifuga Racemosa 12X HPUS	hot flashes
Glonoinum 12X HPUS	occasional sleeplessness, restlessness
Ignatia Amara 12X HPUS	frequent waking, occasional sleeplessness, restlessness
Lachesis 30X HPUS	hot flashes
Pulsatilla 12X HPUS	hot flashes, night sweats
Sepia Officinalis 12X HPUS	irritability, hot flashes, night sweats
Sulphur 12X HPUS	hot flashes, night sweats

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of occasional sleeplessness, restlessness, frequent waking, irritability, hot flashes, and night sweats experienced during menopause.

Warnings

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

Do not use:  • more than directed.  • if you have a known allergy to any ingredient in this product.

Consult a physician if symptoms persist for more than 7 days or worsen.

Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if imprinted tamper-evident bottle sleeve is broken or missing.

In case of emergency

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

Directions

Adults: Take two tablets at onset of symptoms and repeat every four hours as needed.

Inactive ingredients

Acacia Gum, Lactose

Questions or comments?

(800) 624-9659

Principal Display Panel - Doctor Wise Menopause+ Sleep

NDC 54973-3356-1

DOCTOR

WISE

HOMEOPATHY

MENOPAUSE+

SLEEP

Natural relief of occasional

sleeplessness, frequent waking,

hot flashes & night sweats*

SOY

FREE

68 SUBLINGUAL TABLETS

INCLUDES TWO 4-TABLETS SACHETS

carton

MENOPAUSE PLUS SLEEP
atropa belladonna, caulophyllum thalictroides root, black cohosh, nitroglycerin, strychnos ignatii seed, anemone pulsatilla, sepia officinalis juice, sulfur and lachesis muta venom kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3356

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3356-1	1 in 1 CARTON; Type 0: Not a Combination Product	06/01/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 PACKET	4
Part 2	1 BOTTLE, PLASTIC	60

Part 1 of 2

MENOPAUSE PLUS SLEEP
nitroglycerin, strychnos ignatii seed, anemone pulsatilla, black cohosh, lachesis muta venom, sepia officinalis juice, sulfur, atropa belladonna and caulophyllum thalictroides root tablet

Product Information
Item Code (Source)	NDC:54973-3355
Route of Administration	SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X]
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X]
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	12 [hp_X]
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	12 [hp_X]
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	12 [hp_X]
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	30 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white (White to off-white)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3355-2	4 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2018

Part 2 of 2

Product Information
Item Code (Source)	NDC:54973-3355
Route of Administration	SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X]
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	12 [hp_X]
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	12 [hp_X]
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	12 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X]
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	30 [hp_X]
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X]
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white (White to off-white)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3355-1	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2018

Labeler - Hyland's Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc.		008316655	manufacture(54973-3356) , pack(54973-3356) , label(54973-3356)

Name	Address	ID/FEI	Business Operations
Establishment
Merical, Inc		118445308	manufacture(54973-3356)