Calmex by NARTEX LABORATORIOS HOMEOPATICOS SA DE CV CALMEX

Calmex by

Drug Labeling and Warnings

Calmex by is a Homeopathic medication manufactured, distributed, or labeled by NARTEX LABORATORIOS HOMEOPATICOS SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALMEX- ignatia amara, kali phosphoricum, passiflora incarnata, valeriana officinalis tablet 
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV

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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CALMEX

Ignatia Amara 3X

Kali Phsphoricum 6X

Passiflora Incarnata 3X

Valeriana Officinalis 3X

Ignatia Amara 3X............Sleelessness, worry
Kali Phsphoricum 6X........Asthenia, physical and mental exhaustion, nervousness
Passiflora Incarnata 3X.....Nervousness, sleeplessness
Valeriana Officinalis 3X.....Sleeplessness

Provides temporary relief from symptoms of sleeplessness and restlessness due to worry or stress as per Materia Medica.

Stop use and ask a doctor if discomfort persists.

Do not use if you have

an allergy or hypersensitivity to components of the formula.

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 a serious underlying medical illness.

If pregnant or breast feeding ask a health professional before use.

Keep out of the reach of children.

Adults take 2 tablets orally every 4 hours during the day. Dissolves slowly in mouth.

Store in a cool and dry place. 

Grenetina, lactose, magnesium stearate, potato starch, talc, yellow no. 5

P.O. Box 1261, Downey, CA 90240 www.nartexlabs.com

Homeopathic Medicine

Calmex

Passiflora Incarnata
Ignatia Amara
Valeriana Officinalis
Kali Phosphoricum

Mexican Tradition

30 Tablets

Relieves symptoms of sleeplessness, restlessness, and stress

CALMEX 
ignatia amara, kali phosphoricum, passiflora incarnata, valeriana officinalis tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	3 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, POTATO (UNII: 8I089SAH3T)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	yellow (yellow)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	halfcircles
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-003-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/01/2009	12/26/2019

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 SA DE CV (589914576)

Registrant - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV		589914576	manufacture(34666-003)

Revised: 12/2019

Document Id: 9aa2f7a8-d2eb-10e8-e053-2995a90ae25a

34390-5

Set id: 745c46db-06a8-4d25-a74f-a21cd3010b26

Version: 7

Effective Time: 20191226

 

NARTEX LABORATORIOS HOMEOPATICOS SA DE CV