COFFEA CRUDA- coffea cruda 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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Coffea cruda 6X

Active Ingredient:

Coffea cruda 6X

Inactive Ingredients:

Cellulose

Croscarmellose sodium

Lactose

Magesium stearate

Dosage and Administration:
Boericke and Tafel Brand

Directions: Adults or children over 12 years: Take 3 tablets 4-6 times per day. Allow to dissolve under tongue.

Stop when symptoms are relieved.

Indications and Usage:

Helps to reduce difficulty falling asleep.

Purpose:

Helps to reduce difficulty falling asleep.

Warning:

Do not give to children under 12 years of age.

If sleeplessness persists continuously for more than two weeks, consult a 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 heatlhcare 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 two weeks, consult a 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.

21110133 02 Coffea cruda 6X.jpg

COFFEA CRUDA
coffea cruda tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53499-0133
Route of Administration	SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	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:53499-0133-2	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(53499-0133)

Revised: 11/2017

Document Id: 99f11b30-ad57-4f8d-b070-51e1fd173d31

Set id: 035f707d-33f1-46ed-a9f0-5a4a64622bf5

Version: 4

Effective Time: 20171108

Schwabe North America, Inc