Stresscalm Pellets

Stresscalm Pellets
SPL v2
SPL
SPL Set ID ddcbbaae-ca20-9e18-e053-2a95a90a267f
Route
ORAL
Published
Effective Date 2022-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (6 [hp_C]) Atropa Belladonna Chelidonium Majus Calendula Officinalis Flowering Top Abrus Precatorius Seed Viburnum Opulus Bark
Inactive Ingredients
Lactose, Unspecified Form Sucrose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-04-29

Description

Active Ingredients** (in each pellet) Aconitum napellus 6C HPUS (0.07 mg) (contains less than 10 -15 mg aconitine alkaloids) Belladonna 6C HPUS (0.07 mg) (contains less than 10 -15 mg atropine alkaloids) Calendula officinalis 6C HPUS (0.07 mg) Chelidonium majus 6C HPUS (0.07 mg) (contains less than 10 -15 mg chelidonine alkaliods) Jequirity 6C HPUS (0.07 mg) (contains less than 10 -14 indole alkaloids) Viburnum opulus 6C HPUS (0.07 mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Indications and Usage

Uses*

Temporarily relieves symptoms of occasional stress such as:

nervous tension

fatigue

digestive symptoms caused by stress

hypersensitivity to stress or noise

irritability

uneasiness

does not affect alertness

Dosage and Administration
  • Adults and children 12 years of age and older: Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved.
  • Children under 12 years of age: Ask a doctor.

Description

Active Ingredients** (in each pellet) Aconitum napellus 6C HPUS (0.07 mg) (contains less than 10 -15 mg aconitine alkaloids) Belladonna 6C HPUS (0.07 mg) (contains less than 10 -15 mg atropine alkaloids) Calendula officinalis 6C HPUS (0.07 mg) Chelidonium majus 6C HPUS (0.07 mg) (contains less than 10 -15 mg chelidonine alkaliods) Jequirity 6C HPUS (0.07 mg) (contains less than 10 -14 indole alkaloids) Viburnum opulus 6C HPUS (0.07 mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Multi-Symptom

Stress Relief*

Plant-powered Relief

Meltaway Pellets

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Tube - Contains approx. 80 pellets, 3.8 g (0.13 oz)

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

Do not use if pellet dispenser seal is broken.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1

Keep out of reach of children. In case of overdoes, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist continuously for more than 2 weeks or worsen.

Section 51727-6

lactose, sucrose

Section 51945-4

Section 53413-1

BoironUSA.com

[email protected]

1-800-264-7661

Made in France

Disbributed by

Boiron, Inc.

Newtown Square, PA

19073

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose*

Relieves Occasional Stress Symptoms: Nervous Tension, Irritability, Fatigue, and Uneasiness

Section 55106-9

Active Ingredients** (in each pellet)

Aconitum napellus 6C HPUS (0.07 mg) (contains less than 10 -15 mg aconitine alkaloids)

Belladonna 6C HPUS (0.07 mg) (contains less than 10 -15 mg atropine alkaloids)

Calendula officinalis 6C HPUS (0.07 mg)

Chelidonium majus 6C HPUS (0.07 mg) (contains less than 10 -15 mg chelidonine alkaliods)

Jequirity 6C HPUS (0.07 mg) (contains less than 10 -14 indole alkaloids)

Viburnum opulus 6C HPUS (0.07 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Structured Label Content

Indications and Usage (34067-9)

Uses*

Temporarily relieves symptoms of occasional stress such as:

nervous tension

fatigue

digestive symptoms caused by stress

hypersensitivity to stress or noise

irritability

uneasiness

does not affect alertness

Dosage and Administration (34068-7)
  • Adults and children 12 years of age and older: Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved.
  • Children under 12 years of age: Ask a doctor.

Section 42229-5 (42229-5)

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Multi-Symptom

Stress Relief*

Plant-powered Relief

Meltaway Pellets

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Tube - Contains approx. 80 pellets, 3.8 g (0.13 oz)

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

Do not use if pellet dispenser seal is broken.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdoes, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist continuously for more than 2 weeks or worsen.

Section 51727-6 (51727-6)

lactose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com

[email protected]

1-800-264-7661

Made in France

Disbributed by

Boiron, Inc.

Newtown Square, PA

19073

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

Relieves Occasional Stress Symptoms: Nervous Tension, Irritability, Fatigue, and Uneasiness

Section 55106-9 (55106-9)

Active Ingredients** (in each pellet)

Aconitum napellus 6C HPUS (0.07 mg) (contains less than 10 -15 mg aconitine alkaloids)

Belladonna 6C HPUS (0.07 mg) (contains less than 10 -15 mg atropine alkaloids)

Calendula officinalis 6C HPUS (0.07 mg)

Chelidonium majus 6C HPUS (0.07 mg) (contains less than 10 -15 mg chelidonine alkaliods)

Jequirity 6C HPUS (0.07 mg) (contains less than 10 -14 indole alkaloids)

Viburnum opulus 6C HPUS (0.07 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Advanced Ingredient Data


Raw Label Data

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