Coldcalm Pellets

Coldcalm Pellets
SPL v3
SPL
SPL Set ID da32d4e3-f049-e7c8-e053-2a95a90a5790
Route
ORAL
Published
Effective Date 2025-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phytolacca Americana Root (6 [hp_C]) Apis Mellifera (3 [hp_C]) Atropa Belladonna Onion Pulsatilla Vulgaris Dichromate Ion Eupatorium Perfoliatum Flowering Top Gelsemium Sempervirens Root Strychnos Nux-vomica Seed
Inactive Ingredients
Sucrose Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-03-15

Description

Active ingredients** (in each pellet) Allium cepa 3C HPUS (0.05 mg) Apis mellifica 6C HPUS (0.05 mg) Belladonna 6C HPUS (0.05 mg)(contains less than 10 -15 mg atropine alkaloids) Eupatorium perfoliatum 3C HPUS (0.05 mg) Gelsemium sempervirens 6C HPUS (0.05 mg) Kali bichromicum 6C HPUS (0.05 mg) Nux vomica 3C HPUS (0.05 mg) (contains less than 10 -8 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.05 mg) Pulsatilla 6C HPUS (0.05 mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

Do not use if you are allergic to Apis.

Indications and Usage

Uses*

temporarily relieves cold symptoms such as:

▪ sneezing ▪ runny nose ▪ nasal congestion ▪ occasional minor sore throat t

Dosage and Administration

Directions

  • Adults and children 4 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, dissolve 5 pellets under the tongue every 6 hours. Decrease frequency with improvement.

  • Children under 4 years of age: Ask a doctor.
Description

Active ingredients** (in each pellet) Allium cepa 3C HPUS (0.05 mg) Apis mellifica 6C HPUS (0.05 mg) Belladonna 6C HPUS (0.05 mg)(contains less than 10 -15 mg atropine alkaloids) Eupatorium perfoliatum 3C HPUS (0.05 mg) Gelsemium sempervirens 6C HPUS (0.05 mg) Kali bichromicum 6C HPUS (0.05 mg) Nux vomica 3C HPUS (0.05 mg) (contains less than 10 -8 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.05 mg) Pulsatilla 6C HPUS (0.05 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

Other information

  • 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
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if ▪ sore throat worsens or persists for more than 2 days ▪ nasal congestion worsens or lasts more than 5 days in children under 12 years of age or 7 days in adults ▪ new symptoms occur

Section 50569-3

Ask a doctor before use if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.

Section 51727-6

lactose, sucrose

Section 51945-4

Section 53413-1

Questions or comments?

1-800-264-7661

Made in France

Distributed by

Boiron Inc.

Newtown Square, PA

19073

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose*

Relieves Cold Symptoms: Sneezing, Runny Nose, Occasional Minor Sore Throat, and Congestion

Section 55106-9

Active ingredients** (in each pellet)

Allium cepa 3C HPUS (0.05 mg)

Apis mellifica 6C HPUS (0.05 mg)

Belladonna 6C HPUS (0.05 mg)(contains less than 10 -15 mg atropine alkaloids)

Eupatorium perfoliatum 3C HPUS (0.05 mg)

Gelsemium sempervirens 6C HPUS (0.05 mg)

Kali bichromicum 6C HPUS (0.05 mg)

Nux vomica 3C HPUS (0.05 mg) (contains less than 10 -8 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.05 mg)

Pulsatilla 6C HPUS (0.05 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 cold symptoms such as:

▪ sneezing ▪ runny nose ▪ nasal congestion ▪ occasional minor sore throat t

Dosage and Administration (34068-7)

Directions

  • Adults and children 4 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, dissolve 5 pellets under the tongue every 6 hours. Decrease frequency with improvement.

  • Children under 4 years of age: Ask a doctor.
Warnings and Precautions (34071-1)

Do not use if you are allergic to Apis.

Section 42229-5 (42229-5)

Other information

  • 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
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if ▪ sore throat worsens or persists for more than 2 days ▪ nasal congestion worsens or lasts more than 5 days in children under 12 years of age or 7 days in adults ▪ new symptoms occur

Section 50569-3 (50569-3)

Ask a doctor before use if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.

Section 51727-6 (51727-6)

lactose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-264-7661

Made in France

Distributed by

Boiron Inc.

Newtown Square, PA

19073

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

Relieves Cold Symptoms: Sneezing, Runny Nose, Occasional Minor Sore Throat, and Congestion

Section 55106-9 (55106-9)

Active ingredients** (in each pellet)

Allium cepa 3C HPUS (0.05 mg)

Apis mellifica 6C HPUS (0.05 mg)

Belladonna 6C HPUS (0.05 mg)(contains less than 10 -15 mg atropine alkaloids)

Eupatorium perfoliatum 3C HPUS (0.05 mg)

Gelsemium sempervirens 6C HPUS (0.05 mg)

Kali bichromicum 6C HPUS (0.05 mg)

Nux vomica 3C HPUS (0.05 mg) (contains less than 10 -8 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.05 mg)

Pulsatilla 6C HPUS (0.05 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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