Coldcalm Kids Liquid

Coldcalm Kids Liquid
SPL v7
SPL
SPL Set ID 6b3d8ff0-065d-85c4-e053-2991aa0a1788
Route
ORAL
Published
Effective Date 2025-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-05-15
Description

Active ingredients** (in each 1 mL 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 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.

Medication Information

Indications and Usage

Uses*

Temporarily relieves cold symptoms such as:

  • sneezing
  • runny nose
  • nasal congestion
  • occasional minor sore throat
Dosage and Administration

Children 4 years 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 4 years of age: Ask a doctor.

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

Active ingredients** (in each 1 mL 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 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 end 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 and in the box for no longer than 3 months
  • after opening the vial: use product immediately then discard
  • contains 0.0015% alcohol

30 Doses

.034 fl oz (1 mL) per dose

No Known Drug Interactions

Cold Relief*

Sneezy, Runny Nose, Nasal Congestion*

*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
  • new symptoms occur
Section 50569-3

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

Section 51727-6

alcohol, purified water

Section 51945-4

Section 53413-1

ColdCalm.com

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)



Distributed by Boiron Inc. Newtown Square, PA 19073-3267

Section 55105-1

Purpose*

Allium cepa 3C HPUS (0.125 mL) ... Relieves sneezing and runny nose

Apis mellifica 15C HPUS (0.125 mL) ... Relieves nasal congestion

Eupatorium perfoliatum 3C HPUS (0.125 mL) ... Relieves body aches associated with colds

Gelsemium sempervirens 6C HPUS (0.125 mL) ...Relieves headaches associated with colds

Kali bichromicum 6C HPUS (0.125 mL) ... Relieves nasal discharge

Nux vomica 3C HPUS (0.125 mL) ... Relieves sneezing attacks

Phytolacca decandra 6C HPUS (0.125 mL) ... Relieves occasional minor sore throat associated with colds

Pulsatilla 6C HPUS (0.125 mL) ... Relieves colds with a loss of taste and smell

Section 55106-9

Active ingredients** (in each 1 mL 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 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.

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)

Children 4 years 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 4 years of age: Ask a doctor.

  • Tear open the foil pouch at the notched edge.
  • Snap off pre-measured dose.
  • Twist to open.
  • Holding the child upright, squeeze entire contents into mouth.
Section 42229-5 (42229-5)
  • do not use if glued carton end 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 and in the box for no longer than 3 months
  • after opening the vial: use product immediately then discard
  • contains 0.0015% alcohol

30 Doses

.034 fl oz (1 mL) per dose

No Known Drug Interactions

Cold Relief*

Sneezy, Runny Nose, Nasal Congestion*

*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
  • new symptoms occur
Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

alcohol, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

ColdCalm.com

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)



Distributed by Boiron Inc. Newtown Square, PA 19073-3267

Section 55105-1 (55105-1)

Purpose*

Allium cepa 3C HPUS (0.125 mL) ... Relieves sneezing and runny nose

Apis mellifica 15C HPUS (0.125 mL) ... Relieves nasal congestion

Eupatorium perfoliatum 3C HPUS (0.125 mL) ... Relieves body aches associated with colds

Gelsemium sempervirens 6C HPUS (0.125 mL) ...Relieves headaches associated with colds

Kali bichromicum 6C HPUS (0.125 mL) ... Relieves nasal discharge

Nux vomica 3C HPUS (0.125 mL) ... Relieves sneezing attacks

Phytolacca decandra 6C HPUS (0.125 mL) ... Relieves occasional minor sore throat associated with colds

Pulsatilla 6C HPUS (0.125 mL) ... Relieves colds with a loss of taste and smell

Section 55106-9 (55106-9)

Active ingredients** (in each 1 mL 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 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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:06.788422 · Updated: 2026-03-14T23:17:29.613906