IGNATIA AMARA- ignatia amara tablet
Natures Way Holding Co.

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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Ignatia amara 6X

Active Ingredient:

Ignatia amara 6X

Inactive Ingredients:Cellulose

Croscarmellose sodium

Lactose

Magnesium stearate

Dosage and Administration:

Directions: Adults or children over 12 years: take 3 tablets 4-6 times a day.

Allow to dissolve under tongue.

Stop when symptoms are relieved.

Indications and Usage:

Helps to reduce difficulty falling asleep.

Warning:

Do no give to children under 12 years of age.

If sleeplessness persists continuously for more than 2 weeks, consult your doctor.

Insomnia may be a symptom of serious underlying medical illness.

Avoid alcoholic beverages while taking this product.

Do not take this product if you are taking sedatives or tranquilizers, without first consulting a doctor.

Pregnancy or Breast Feeding:

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children

Ask the Doctor:

Do no give to children under 12 years of age.

If sleeplessness persists continuously for more than 2 weeks, consult your doctor.

Insomnia may be a symptom of serious underlying medical illness.

Avoid alcoholic beverages while taking this product.

Do not take this product if you are taking sedatives or tranquilizers, without first consulting a doctor.

Overdosage:
In case of overdose, seek medical help or contact a Poison Control Center immediately.

Purpose:

Helps to reduce difficulty falling asleep.

Package Label and Principal Display: Boericke and Tafel Brand 21116333

21116333 02 Ignatia Amara 6X 100.jpg

21116333 02 Ignatia Amara 6X 100

IGNATIA AMARA
ignatia amara tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53499-6333
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	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white (white tablet)	Score	no score
Shape	ROUND (B&T)	Size	6mm
Flavor		Imprint Code	B;T
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53499-6333-2	100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2006	01/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2006	01/31/2015

Labeler - Natures Way Holding Co. (153970520)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-6333)

Revised: 8/2016

Document Id: 678dad1c-c33d-4a27-ba29-b9990a496f07

Set id: c219d41f-d413-4e22-8e6c-9ab2340690a3

Version: 3

Effective Time: 20160818

Natures Way Holding Co.