IGNATIA AMARA- ignatia amara tablet
Schwabe North America, Inc.

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 30X

Active Ingredient:

Ignatia amara 30X

Inactive Ingredients:
Cellulose
Croscarmellose sodium
Lactose
Magnesium stearate

Dosage and Administration:

Boericke and Tafel Brand:

Directions: Adults or children over 12 years: take 3 tablets 1-3 times a day.

Allow to dissolve under tongue.

Stop when symptoms are relieved.

Indications and Usage:

Helps to reduce difficulty falling asleep.

Warnings:

Do not 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 your doctor.

Pregnancy or Breast Feeding:

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

Keep Out of Reach of Children:

Keep out of reach of children.

Ask the Doctor:

Do not 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 your 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 Ignatia Amara 21116373 100 tablets

21116373 02 IgnatiaAmara 30X 100.jpg

IGNATIA AMARA
ignatia amara tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53499-6372
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	30 [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:53499-6372-2	100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2006	02/28/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2006	02/28/2019

Labeler - Schwabe North America, Inc. (831153908)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-6372)

Revised: 3/2017

Document Id: eae941e0-e1e7-4fdd-8158-6a828f0416f5

Set id: ec915ea9-967f-4061-8a8e-7ac3a9270d60

Version: 3

Effective Time: 20170309

Schwabe North America, Inc.

Ignatia amara 30X

Package Label and Principal Display Boericke and Tafel Ignatia Amara 21116373 100 tablets

Package Label and Principal Display
Boericke and Tafel Ignatia Amara 21116373 100 tablets