Coldcalm

Coldcalm
SPL v14
SPL
SPL Set ID af4a4765-8255-44fb-821c-4345a2a45e2a
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1995-01-01

Description

Active ingredients** (in each tablet) Allium cepa 3C HPUS (0.28 mg) Apis mellifica 6C HPUS (0.28 mg) Belladonna 6C HPUS (0.28 mg) (contains less than 10 -14 mg atropine alkaloids) Eupatorium perfoliatum 3C HPUS (0.28 mg) Gelsemium sempervirens 6C HPUS (0.28 mg) (contains less than 10 -14 gelsemine alkaloids) Kali bichromicum 6C HPUS (0.28 mg) (contains less than 10 -13 mg chromium) Nux vomica 3C HPUS (0.28 mg) (contains less than 10 -8 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.28 mg) Pulsatilla 6C HPUS (0.28 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
Dosage and Administration

Directions

  • Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets every 6 hours. Decrease frequency with improvement.
  • Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.
Description

Active ingredients** (in each tablet) Allium cepa 3C HPUS (0.28 mg) Apis mellifica 6C HPUS (0.28 mg) Belladonna 6C HPUS (0.28 mg) (contains less than 10 -14 mg atropine alkaloids) Eupatorium perfoliatum 3C HPUS (0.28 mg) Gelsemium sempervirens 6C HPUS (0.28 mg) (contains less than 10 -14 gelsemine alkaloids) Kali bichromicum 6C HPUS (0.28 mg) (contains less than 10 -13 mg chromium) Nux vomica 3C HPUS (0.28 mg) (contains less than 10 -8 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.28 mg) Pulsatilla 6C HPUS (0.28 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 the blister seal is broken
  • store below 86° F (30° C)

Contains 20 meltaway tablets unflavored

Contains 60 meltaway tablets unflavored

Contains 100 meltway tablets unflavored

Contains 120 meltaway tablets unflavored

No Known Drug Interactions

Phenylephrine-free

Non-Drowsy

Cold Relief*

Sneezing, Runny Nose, Minor Sore Throat*

*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 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

  • in children under 4 years of age
  • if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting
Section 51727-6

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

Questions or comments



ColdCalm.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

Section 53414-9

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

Section 55105-1

Purpose*

Allium cepa 3C HPUS ... Relieves sneezing and runny nose

Apis mellifica 6C HPUS ... Relieves nasal congestion

Belladonna 6C HPUS ... Relieves colds with a sudden onset

Eupatorium perfoliatum 3C HPUS ... Relieves aches and pain associated with colds

Gelsemium sempervirens 6C HPUS ... Relieves headaches associated with colds

Kali bichromicum 6C HPUS ... Relieves nasal discharge

Nux vomica 3C HPUS .... Relieves sneezing fits

Phytolacca decandra 6C HPUS ... Relieves occasional minor sore throat associated with colds

Pulsatilla 6C HPUS ... Relieves colds with a loss of taste and smell

Section 55106-9

Active ingredients** (in each tablet)

Allium cepa 3C HPUS (0.28 mg)

Apis mellifica 6C HPUS (0.28 mg)

Belladonna 6C HPUS (0.28 mg) (contains less than 10 -14 mg atropine alkaloids)

Eupatorium perfoliatum 3C HPUS (0.28 mg)

Gelsemium sempervirens 6C HPUS (0.28 mg) (contains less than 10 -14 gelsemine alkaloids)

Kali bichromicum 6C HPUS (0.28 mg) (contains less than 10 -13 mg chromium)

Nux vomica 3C HPUS (0.28 mg) (contains less than 10 -8 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.28 mg)

Pulsatilla 6C HPUS (0.28 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
Dosage and Administration (34068-7)

Directions

  • Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets every 6 hours. Decrease frequency with improvement.
  • Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.
Warnings and Precautions (34071-1)



Do not use if you are allergic to Apis.

Section 42229-5 (42229-5)
  • do not use if glued carton end flaps are open or if the blister seal is broken
  • store below 86° F (30° C)

Contains 20 meltaway tablets unflavored

Contains 60 meltaway tablets unflavored

Contains 100 meltway tablets unflavored

Contains 120 meltaway tablets unflavored

No Known Drug Interactions

Phenylephrine-free

Non-Drowsy

Cold Relief*

Sneezing, Runny Nose, Minor Sore Throat*

*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 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

  • in children under 4 years of age
  • if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting
Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments



ColdCalm.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose*

Allium cepa 3C HPUS ... Relieves sneezing and runny nose

Apis mellifica 6C HPUS ... Relieves nasal congestion

Belladonna 6C HPUS ... Relieves colds with a sudden onset

Eupatorium perfoliatum 3C HPUS ... Relieves aches and pain associated with colds

Gelsemium sempervirens 6C HPUS ... Relieves headaches associated with colds

Kali bichromicum 6C HPUS ... Relieves nasal discharge

Nux vomica 3C HPUS .... Relieves sneezing fits

Phytolacca decandra 6C HPUS ... Relieves occasional minor sore throat associated with colds

Pulsatilla 6C HPUS ... Relieves colds with a loss of taste and smell

Section 55106-9 (55106-9)

Active ingredients** (in each tablet)

Allium cepa 3C HPUS (0.28 mg)

Apis mellifica 6C HPUS (0.28 mg)

Belladonna 6C HPUS (0.28 mg) (contains less than 10 -14 mg atropine alkaloids)

Eupatorium perfoliatum 3C HPUS (0.28 mg)

Gelsemium sempervirens 6C HPUS (0.28 mg) (contains less than 10 -14 gelsemine alkaloids)

Kali bichromicum 6C HPUS (0.28 mg) (contains less than 10 -13 mg chromium)

Nux vomica 3C HPUS (0.28 mg) (contains less than 10 -8 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.28 mg)

Pulsatilla 6C HPUS (0.28 mg)

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


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Raw Label Data

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