Coldcalm Tablet
FDA Label NDC 0220-9048

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Coldcalm (NDC 0220-9048). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Ask Doctor

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other

→ Inactive Ingredient

→ Otc - Questions

→ Otc - When Using

→ Otc - Do Not Use

→ How Supplied

→ Storage And Handling

→ Drug Interactions

→ Package Label.principal Display Panel

Otc - Active Ingredient

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 ^-14gelsemine alkaloids)

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

Nux vomica 3C HPUS (0.28 mg)**

Phytolacca decandra 6C HPUS (0.28 mg)**

Pulsatilla 6C HPUS (0.28 mg)**

(in each tablet)

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

Otc - 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 attacks*

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

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

Indications & Usage

temporarily relieves cold symptoms such as:

sneezing
runny nose
nasal congestion
minor sore throat

Warnings

Otc - Ask Doctor

Ask a doctor before use

in children under 3 years of age
if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist for more than 2 days or worsen, or if new symptoms occur.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets under the tongue every 15 minutes for 1 hour. Then, take 2 tablets every 6 hours. Decrease frequency with improvement.
Children 3 to 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

Other

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

Contains 60 meltaway tablets unflavored

Contains 120 meltaway tablets unflavored

No Known Drug Interactions

For Ages 3 & Up

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.