FDA.reportPublic FDA data

CALM-ITO

Manufacturer
Nartex Laboratorios Homeopaticos, S.A. de C.V.
Effective date
2016-05-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 01:26:20

Label at a glance#

ProductCALM-ITO
Active ingredientCOFFEE BEAN, CYPRIPEDIUM PARVIFOLUM ROOT, MATRICARIA RECUTITA, HYOSCYAMUS NIGER
Label structure11 sections

Storage and handling

store in a cool and dry place

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

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

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

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

OTC - PURPOSE SECTION

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.

INDICATIONS & USAGE SECTION

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.

WARNINGS SECTION

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

OTC - STOP USE SECTION

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
OTC - WHEN USING SECTION

Avoid

  • alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store in a cool and dry place

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

DESCRIPTION SECTION

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

DESCRIPTION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

CalmitoCartonCalmitoCarton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Coffee BeanACTIVE INGREDIENTJFH385Y7443
CYPRIPEDIUM PUBESCENSACTIVE INGREDIENT21Y9GZ1LZA3
HYOSCYAMUSACTIVE INGREDIENT5DT0PFG1843
MATRICARIAACTIVE INGREDIENTG0R4UBI2ZZ3
COFFEE BEANACTIVE MOIETYJFH385Y7443
CYPRIPEDIUM PUBESCENSACTIVE MOIETY21Y9GZ1LZA3
HYOSCYAMUSACTIVE MOIETY5DT0PFG1843
MATRICARIAACTIVE MOIETYG0R4UBI2ZZ3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-00534666-005-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
COFFEE BEANJFH385Y744ACTIB
CYPRIPEDIUM PARVIFOLUM ROOT21Y9GZ1LZAACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9aa32c62-7161-1d3e-e053-2a95a90a054186a856d1-1497-4fce-a96d-139ecea1a1d22019-12-26WarningsExact identifier
spl set id: 86a856d1-1497-4fce-a96d-139ecea1a1d2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.