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  5. Label Information: Coldcalm

FDA Label for Coldcalm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. OTC - ASK DOCTOR
    5. OTC - STOP USE
    6. WARNINGS
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENT
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPLE DISPLAY PANEL - COLDCALM

Coldcalm Product Label

The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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