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

Menopause Plus Sleep by

Drug Labeling and Warnings

Menopause Plus Sleep by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Hoemopathic Company, Merical, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Belladonna 12X HPUS, Caulophyllum 12X HPUS, Cimicifuga Racemosa 12X HPUS, Glonoinum 12X HPUS, Ignatia Amara 12X HPUS, Lachesis 30X HPUS, Pulsatilla 12X HPUS, Sepia Officinalis 12X HPUS, Sulphur 12X HPUS.

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

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 - 60 Sublingual Tablet Bottle Label

DOCTOR

WISE

HOMEOPATHY

MENOPAUSE+

SLEEP

Natural relief of occasional

sleeplessness, frequent waking,

hot flashes & night sweats

60 SUBLINGUAL TABLETS

INGREDIENTS AND APPEARANCE

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
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3355
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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]
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X]
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	12 [hp_X]
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	30 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	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]

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3355-1	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018
2	NDC: 54973-3355-2	4 in 1 PACKET; Type 0: Not a Combination Product	06/01/2018

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

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Hoemopathic Company		008316655	manufacture(54973-3355) , pack(54973-3355) , label(54973-3355)

Establishment
Name	Address	ID/FEI	Business Operations
Merical, Inc		118445308	manufacture(54973-3355) , pack(54973-3355) , label(54973-3355)