Coffea cruda 30C

Drug Details [pdf]

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 30C

Active Ingredient:

Coffea cruda 30C

Inactive Ingredients:

CELLULOSE

LACTOSE

MAGNESIUM STEARATE

CROSCARMELLOSE SODIUM

Dosage:

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:

Helps to reduce difficulty falling asleep.

Purpose:

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.

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

Keep out of reach of children.

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

Children:

Keep out of reach of children.

Pregnancy and Breast Feeding:

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

Overdosage:

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

Ask the Doctor:

Do not give to children under 12 years of age.

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

Insomnia may be a symptom of serious underlying medical illness.

Avoid alcoholic beverages while taking this product.

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

Package Label and Principal Display:

21210173 02 Coffea cruda 30C

COFFEA CRUDA
coffea cruda tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-0171
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	30 [hp_C]

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: 53499-0171-2	100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2006	04/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2006	04/30/2019

Labeler - Schwabe North America, Inc. (831153908)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-0171)

Revised: 11/2017

Document Id: dc037233-4abb-4416-b961-cffc74756a5b

Set id: 909ad221-3b82-498a-8403-f2bde418afe8

Version: 5

Effective Time: 20171108

Schwabe North America, Inc.

Coffea cruda 30C

Drug Labeling and Warnings

Drug Details [pdf]

Coffea cruda 30C