CALM-ITO by Nartex Laboratorios Homeopaticos, S.A. de C.V.

CALM-ITO by

Drug Labeling and Warnings

CALM-ITO by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratorios Homeopaticos, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALM-ITO- coffea cruda, cypripendium, hyoscyamus and matricaria chamomilla tablet 
Nartex Laboratorios Homeopaticos, S.A. de C.V.

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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Chamomilla.................3X HPUS

Coffea Cruda...............3X HPUS

Cypripedium................3X HPUS

Hyoscayamus...............3X HPUS

Chamomilla.................3X HPUS*.............Oversensitivity and sleeplessness

Coffea Cruda...............3X HPUS*........................Anxiety and sleeplessness

Cypripedium................3X HPUS*................................Nervousness in kids

Hyoscayamus...............3X HPUS*.....................Insomnia, scaared wake-up

*The letters "HPUS" indicate that hte components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. X is an homeopathic dilution. See www.nartexlabsusa.com for more information. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Helps relieve symptoms such as:

• irritability
• crying
• oversensitivity
• restlessness
• sleeplessness

as per Materia Medica

Product uses are based on Homeopathic Materia Medica. These "Uses" have not been evaluated by the Food and Drug Administration. This product has not been clinically tested by Nartex Labs USA, Inc.

Do not use

• if you have an allergy or hypersensitivity to components of the formulathis product except under advise and supervision of a physician
• if you are allergic to milk or milk products

Stop use and ask a physician if

• discomfort persists for more than 8 hours
• If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical issues

Avoid

• alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

• adults and children over 2 years take 3 tablets every 4 hours

store in a cool and dry place

Citric acid, lactose, magnesium stearate, sodium benzoate, sucrose

informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

Product claims are based on Homeopathic Materia Medica. This product has not been clinically tested by Nartex.

Keep carton. It contains important information.

For your protection, this bottle has a seal around the neck. Attention: do not use if the neck seal is broken.

This product is HOMEOPATHIC. Its claims and efficacy are based on homeopathic research and clinical experience. This product has not been evaluated for efficacy by FDA with the same rules and procedures as those for other non-homeopathic drugs. For more information on homeopathy vists www.nartexlabsusa.com before using this product.

NDC: 34666-005-10

Calmito

Coffea cruda Cypripedium Hyoscyamus Chamomilla

Children irritability*

tablets

Homeopathic

Directions

Take 3 tablets every 4 hours**

Grape flavor

100 tablets

*BASED ON HOMEOPATHIC MATERIA MEDICA

**SEE DIRECTIONS AT THE BACK

CALM-ITO 
coffea cruda, cypripendium, hyoscyamus and matricaria chamomilla tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744)	COFFEE BEAN	3 [hp_X]
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT	3 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-005-10	1 in 1 PACKAGE	08/01/2009	12/26/2019
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/01/2009	12/26/2019

Labeler - Nartex Laboratorios Homeopaticos, S.A. de C.V. (589914576)

Registrant - Nartex Laboratorios Homeopaticos, S.A. de C.V. (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratorios Homeopaticos, S.A. de C.V.		589914576	manufacture(34666-005)

Revised: 12/2019

Document Id: 9aa32c62-7161-1d3e-e053-2a95a90a0541

34390-5

Set id: 86a856d1-1497-4fce-a96d-139ecea1a1d2

Version: 7

Effective Time: 20191226

 

Nartex