OHM-INS- avena sativa, coffea cruda, ignatia amara, passiflora incarnata, valeriana officinalis spray
OHM PHARMA 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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OHM-INS

ACTIVE INGREDIENTS (HPUS) - equal amounts of: Avena Sativa 5X, Coffea Cruda 30C, Ignatia Amara 14X, Passiflora Incarnata 5X, Valeriana Officinalis 5X.

Venta bajo prescriptin medica.

Medicamento Homeopatico.

Mantengase fuera del alcance de los nios.

DIRECTIONS: Shake 10 times before use. Spray 3 times directly under the tongue 2-3 times during the night or as directed by a health professional. Children under 12 years use half adult dose.

Manufactured according to HPUS standards.

CONDICIONES DE ALMACENAMIENTO: Conservar el producto protegido del calor, luz y humedad. Alcamacenat a no mas de 30C.

INACTIVE INGREDIENT: USP Ethanol Alcohol 20%

Mfg. By: OHM PHARMA INC.

Mineral Wells, TX 76067

R.S. INVIMA: MH2011-0001779

Importado y Distribuido para Colombia por:

OHM PHARMA COLOMBIA Ltda.

DG. 39 NO 34 C SUR 30

Envigado, Antioquia

Tel: (57) 4-379 5995

NDC: 66096-123-02

OHM-INS

Medicamento Homeopatico

Natural - Safe - Effective

No Side Effects - Non Habit Forming

1oz bottle label

Sleeplessness/Insomnia Relief

OHM-INS
avena sativa, coffea cruda, ignatia amara, passiflora incarnata, valeriana officinalis spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66096-123
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	5 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	30 [hp_C] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	14 [hp_X] in 1 mL
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA TOP	5 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	5 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66096-123-02	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2010	02/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2010	02/21/2020

Labeler - OHM PHARMA INC. (030572478)

Registrant - OHM PHARMA INC. (030572478)

Name	Address	ID/FEI	Business Operations
Establishment
OHM PHARMA INC.		030572478	manufacture(66096-123)

Revised: 3/2021

Document Id: ad47a413-007e-49a8-82f1-9f1af72aa9db

Set id: 72181ad2-160f-4018-a5d6-c07923d139ac

Version: 4

Effective Time: 20210324

OHM PHARMA INC.