Coldcalm Liquid

Coldcalm Liquid
SPL v13
SPL
SPL Set ID 94afe9a0-2d11-11e7-818f-424c58303031
Route
ORAL
Published
Effective Date 2025-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (3 [hp_C]) Apis Mellifera (15 [hp_C]) Eupatorium Perfoliatum Flowering Top (6 [hp_C]) Gelsemium Sempervirens Root Dichromate Ion Strychnos Nux-vomica Seed Phytolacca Americana Root Pulsatilla Vulgaris
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-05-01

Description

Active ingredients** (in each 1mL vial) Allium cepa 3C HPUS (0.125 mL) Apis mellifica 15C HPUS (0.125 mL) Eupatorium perfoliatum 3C HPUS (0.125 mL) Gelsemium sempervirens 6C HPUS (0.125 mL) (contains less than 10 -11 mg gelsemine alkaloids) Kali bichromicum 6C HPUS (0.125 mL) (contains less than 10 -10 mg chromium) Nux vomica 3C HPUS (0.125 mL) (contains less than 10 -5 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.125 mL) Pulsatilla 6C HPUS (0.125 mL) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Purpose* Allium cepa 3C HPUS ... Relieves sneezing and runny nose Apis mellifica 15C HPUS ... Relieves nasal congestion Eupatorium perfoliatum 3C HPUS ... Relieves body aches 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 mild fever Pulsatilla 6C HPUS ... Relieves colds with a loss of taste and smell


Medication Information

Indications and Usage

Uses*

temporarily relieves cold symptoms such as:

  • sneezing
  • runny nose
  • nasal congestion
Purpose

Purpose*

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



Apis mellifica 15C HPUS ... Relieves nasal congestion



Eupatorium perfoliatum 3C HPUS ... Relieves body aches 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 mild fever



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

Description

Active ingredients** (in each 1mL vial) Allium cepa 3C HPUS (0.125 mL) Apis mellifica 15C HPUS (0.125 mL) Eupatorium perfoliatum 3C HPUS (0.125 mL) Gelsemium sempervirens 6C HPUS (0.125 mL) (contains less than 10 -11 mg gelsemine alkaloids) Kali bichromicum 6C HPUS (0.125 mL) (contains less than 10 -10 mg chromium) Nux vomica 3C HPUS (0.125 mL) (contains less than 10 -5 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.125 mL) Pulsatilla 6C HPUS (0.125 mL) 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 flaps are open or if inner foil pouch and vials are not intact

do not refrigerate or freeze

after opening foil pouch: store unused vials in the foil pouch for no longer than 3 months

after opening the vial: use product immediately then discard

contains 0.0015% alcohol

Cold Relief*

Sneezing, Runny Nose, Nasal Congestion*

No Known Drug Interactions

40 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

30 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

5 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

*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 doctor if sore throat, vomiting, skin rash, diarrhea, difficulty breathing, or fever above 100 o F (38 o C) develops, or if symptoms persist for more than 2 days or worsen, or new symptoms occur.

Section 51727-6

alcohol, purified water

Section 51945-4

Directions

Children 6 months of age and older:

Give 1 dose at the onset of symptoms. Repeat up to 6 times a day. Decrease frequency with improvement.

Children under 6 months of age:

Ask a doctor.

  • Tear open the foil pouch at the notched edge.
  • Snap off one pre-measured dose.
  • Twist to open.
  • Holding the child upright, squeeze entire contents into mouth.
Active Ingredients

Active ingredients** (in each 1mL vial)

Allium cepa 3C HPUS (0.125 mL)

Apis mellifica 15C HPUS (0.125 mL)

Eupatorium perfoliatum 3C HPUS (0.125 mL)

Gelsemium sempervirens 6C HPUS (0.125 mL) (contains less than 10 -11 mg gelsemine alkaloids)

Kali bichromicum 6C HPUS (0.125 mL) (contains less than 10 -10 mg chromium)

Nux vomica 3C HPUS (0.125 mL) (contains less than 10 -5 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.125 mL)

Pulsatilla 6C HPUS (0.125 mL)

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

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


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves cold symptoms such as:

  • sneezing
  • runny nose
  • nasal congestion
Section 42229-5 (42229-5)

do not use if glued carton flaps are open or if inner foil pouch and vials are not intact

do not refrigerate or freeze

after opening foil pouch: store unused vials in the foil pouch for no longer than 3 months

after opening the vial: use product immediately then discard

contains 0.0015% alcohol

Cold Relief*

Sneezing, Runny Nose, Nasal Congestion*

No Known Drug Interactions

40 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

30 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

5 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

*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 doctor if sore throat, vomiting, skin rash, diarrhea, difficulty breathing, or fever above 100 o F (38 o C) develops, or if symptoms persist for more than 2 days or worsen, or new symptoms occur.

Section 51727-6 (51727-6)

alcohol, purified water

Section 51945-4 (51945-4)

Purpose

Purpose*

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



Apis mellifica 15C HPUS ... Relieves nasal congestion



Eupatorium perfoliatum 3C HPUS ... Relieves body aches 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 mild fever



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

Directions

Children 6 months of age and older:

Give 1 dose at the onset of symptoms. Repeat up to 6 times a day. Decrease frequency with improvement.

Children under 6 months of age:

Ask a doctor.

  • Tear open the foil pouch at the notched edge.
  • Snap off one pre-measured dose.
  • Twist to open.
  • Holding the child upright, squeeze entire contents into mouth.
Active Ingredients

Active ingredients** (in each 1mL vial)

Allium cepa 3C HPUS (0.125 mL)

Apis mellifica 15C HPUS (0.125 mL)

Eupatorium perfoliatum 3C HPUS (0.125 mL)

Gelsemium sempervirens 6C HPUS (0.125 mL) (contains less than 10 -11 mg gelsemine alkaloids)

Kali bichromicum 6C HPUS (0.125 mL) (contains less than 10 -10 mg chromium)

Nux vomica 3C HPUS (0.125 mL) (contains less than 10 -5 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.125 mL)

Pulsatilla 6C HPUS (0.125 mL)

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

Questions Or Comments? (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)