Label: ANIMAL CALM- aconitum napellus, adrenalinum, asarum canadense, cerebrum suis, chamomilla, gelsemium sempervirens, kali phosphoricum, passiflora incarnata, phosphorus, rhododendron chrysanthum, stramonium, valeriana officinalis liquid
- NDC Code(s): 86210-0001-1
- Packager: DB Pets LLC
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 1, 2024
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- ACTIVE INGREDIENTS:
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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
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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:
- KEEP OUT OF THE REACH OF CHILDREN:
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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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 liquidProduct 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