ANIMAL CALM- aconitum napellus, adrenalinum, asarum canadense, cerebrum suis, chamomilla, gelsemium sempervirens, kali phosphoricum, passiflora incarnata, phosphorus, rhododendron chrysanthum, stramonium, valeriana officinalis liquid

Animal Calm by

Drug Labeling and Warnings

Animal Calm by is a Homeopathic medication manufactured, distributed, or labeled by DB Pets LLC, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Aconitum Napellus 30X, Adrenalinum 12X, 30X, Asarum Canadense 12X, Cerebrum Suis 8X, Chamomilla 12X, Gelsemium Sempervirens 30X, Kali Phosphoricum 6X, Passiflora Incarnata 6X, Phosphorus 8X, 12X, 30X, Rhododendron Chrysanthum 12X, Stramonium 30X, Valeriana Officinalis 6X.

PURPOSE:

Aconitum Napellus - Fear, Adrenalinum - Stress, Asarum Canadense – Sensitivity to Noise, Cerebrum Suis - Restlessness, Chamomilla – Travel Stress, Gelsemium Sempervirens - Anxiety, Kali Phosphoricum - Fear, Passiflora Incarnata - Overexcitement, Phosphorus – Fear of Thunderstorms, Rhododendron Chrysanthum – Sensitivity to Noise, Stramonium – Separation Anxiety, Valeriana Officinalis – Calm Territorial Disputes

USES:

For the temporary relief of symptoms including:

fear stress sensitivity to noise restlessness travel stress anxiety

overexcitement separation anxiety fear of thunderstorms calm territorial disputes 

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

If your pet is pregnant or breastfeeding, ask a veterinarian before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

KEEP OUT OF THE REACH OF CHILDREN:

In case of overdose, contact a physician or Poison Control Center right away.

DIRECTIONS:

3-10 drops 3 times a day, 15 minutes before meals in water bowl or on a treat. In acute situations, 10 drops every 15 minutes up to 6 intakes per day. Discontinue when symptoms stop. Repeat dose when symptoms reappear. Consult a veterinarian if symptoms persist.

INACTIVE INGREDIENTS:

Demineralized water, 25% ethanol

QUESTIONS:

Dist. By: DB Pets, LLC

461 W. Parkland Drive

Sandy, UT 84070

www.dbpets.com

800-827-9529

PACKAGE LABEL DISPLAY:

DB pets

Animal Calm

Homeopathic

NDC: 86210-0001-1

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

ANIMAL CALM 
aconitum napellus, adrenalinum, asarum canadense, cerebrum suis, chamomilla, gelsemium sempervirens, kali phosphoricum, passiflora incarnata, phosphorus, rhododendron chrysanthum, stramonium, valeriana officinalis liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86210-0001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS WHOLE	30 [hp_X]  in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	12 [hp_X]  in 1 mL
ASARUM CANADENSE ROOT (UNII: E2O4O7TQYK) (ASARUM CANADENSE ROOT - UNII:E2O4O7TQYK)	ASARUM CANADENSE ROOT	12 [hp_X]  in 1 mL
SUS SCROFA CEREBRUM (UNII: 4GB5DQR532) (SUS SCROFA CEREBRUM - UNII:4GB5DQR532)	SUS SCROFA CEREBRUM	8 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	12 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	30 [hp_X]  in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	6 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	8 [hp_X]  in 1 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	12 [hp_X]  in 1 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	30 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86210-0001-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/01/2024

Labeler - DB Pets LLC (132119169)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture, api manufacture, label, pack