H-CALM FORMULA- aconitum napellus, alfalfa, avena sativa, chamomilla, cistus canadensis, clematis vitalba, flos, impatiens glandulifera, flos, kali phosphoricum, lilium tigrinum, ornithogalum umbellatum, flos, passiflora incarnata, phosphorus, prunus cerasifera, flos, pulsatilla, valeriana officinalis spray

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients

Aconitum napellus

Alfalfa

Avena sativa

Chamomilla

Cistus canadensis

Clematis vitalba, flos

Impatiens glandulifera, flos

Kali phosphoricum

Lilium tigrinum

Ornithogalum umbellatum, flos

Passiflora incarnata

Phosphorus

Prunus cerasifera, flos

Pulsatilla

Valeriana officinalis

Purpose

Aconitum napellus...........................Fear

Alfalfa...........................Vitality

Avena sativa...........................Exhaustion

Chamomilla...........................Irritability

Cistus canadensis...........................Apprehension

Clematis vitalba, flos...........................Dreaminess

Impatiens glandulifera, flos...........................Impatience

Kali phosphoricum...........................Fatigue

Lilium tigrinum...........................Anxiety

Ornithogalum umbellatum, flos...........................Shock

Passiflora incarnata...........................Nervousness

Phosphorus...........................Weakness

Prunus cerasifera, flos...........................Control

Pulsatilla...........................Moodiness

Valeriana officinalis...........................Restlessness

Uses

For temporary relief of symptoms such as:

• restlessness
• tension
• irritability
• agitation

+as per various homeopathic materia medicas. Claims are based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evalutaed by the Food and Drug Administration. Product has not been clinically tested.

Warnings

• Stop use and consult a physician if symptoms worsen or persist for more than 7 days

• If pregnant or breast-feeding, ask a healthcare professional before use

• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Directions

• Depress pump to prime
• Spray one dose directly into mouth
• Adults & children over 12 years: 3 sprays 3 times per day
• Children 6-12 years: 2 sprays 3 times per day
• Consult a physician for use in children under 6 years old
• Use additionally as needed, up to 6 times per day

Other information

• Store at room temperature 68-77F (20-25C)
• Avoid direct sunlight and excessive heat
• Do not use if safety seal is broken or missing

Inactive ingredients

Citric Acid, Potassium Sorbate, USP Purified Water

PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H-Calm Formula

Homeopathic

For temporary relief of:

Restlessness

Irritability

2 fl oz (59 mL)

amoils.com

INGREDIENTS AND APPEARANCE

H-CALM FORMULA 
aconitum napellus, alfalfa, avena sativa, chamomilla, cistus canadensis, clematis vitalba, flos, impatiens glandulifera, flos, kali phosphoricum, lilium tigrinum, ornithogalum umbellatum, flos, passiflora incarnata, phosphorus, prunus cerasifera, flos, pulsatilla, valeriana officinalis spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61077-502
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CROCANTHEMUM CANADENSE (UNII: 46G3W789Q3) (CROCANTHEMUM CANADENSE - UNII:46G3W789Q3)	CROCANTHEMUM CANADENSE	10 [hp_X]  in 59 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X]  in 59 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	10 [hp_X]  in 59 mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B)	ORNITHOGALUM UMBELLATUM FLOWERING TOP	10 [hp_X]  in 59 mL
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	10 [hp_X]  in 59 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	10 [hp_X]  in 59 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	10 [hp_X]  in 59 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	10 [hp_X]  in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	10 [hp_X]  in 59 mL
PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV)	PULSATILLA VULGARIS WHOLE	10 [hp_X]  in 59 mL
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	10 [hp_X]  in 59 mL
PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS)	PRUNUS CERASIFERA FLOWER	10 [hp_X]  in 59 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X]  in 59 mL
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD)	ALFALFA	10 [hp_X]  in 59 mL
CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI)	CLEMATIS VITALBA FLOWER	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61077-502-59	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/07/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/07/2026

Labeler - Healing Natural Oils LLC (113679703)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(61077-502)