Coldcalm Liquid
FDA Label NDC 0220-9057

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 0220-9057). 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 active ingredients, purpose, uses, otc - ask doctor, otc - stop use, warnings, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Allium cepa 3C, Apis mellifica 15C, Eupatorium perfoliatum 3C, Gelsemium sempervirens 6C, Kali bichromicum 6C, Nux vomica 3C, Phytolacca decandra 6C, Pulsatilla 6C

Purpose

Allium cepa 3C Relieves sneezing and runny nose
Apis mellifica 15C Relieves nasal congestion
Eupatorium perfoliatum 3C Relieves body aches associated with colds
Gelsemium sempervirens 6C Relieves headeaches associated with colds
Kali bichromicum 6C Relieves nasal discharge
Nux vomica 3C Relieves sneezing attacks
Phytolacca decandra 6C Relieves mild fever
Pulsatilla 6C Relieves colds with a loss of taste and smell

Uses

Temporary relieves cold symptoms such as sneezing, runny nose, and nasal congestion.

Otc - Ask Doctor

Ask a doctor before use in children under 6 months of age.

Otc - Stop Use

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.

Warnings

After administering, discard single use container.
Do not reuse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Children 6 months of age and older:
Administer one liquid unit-dose at the onset of symptoms, 3 to 6 times a day.
Reduce with improvement.
Keep the remaining unit-doses in the aluminum pouch.

Other Information

Do not use if glued carton end flaps, inner foil pouch, and single-user container are not intact
Before opening the foil pack: No specific storage conditions.
After opening the foil pack: Store the unused does in the foil pack at a temperature that does not exceed 77 o F (25 o C).
After opening the unit dose: The product must be used immediately.
Do not refrigerate or freeze.

Inactive Ingredient

purified water

Questions Or Comments?

ColdCalm.com
BoironUSA.com
[email protected]
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA
19073-3267

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