FDA Label for Coldcalm
View Indications, Usage & Precautions
- 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
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.
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 -14 gelsemine 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.
Inactive Ingredient
Croscarmellose sodium, lactose, magnesium stearate
Otc - Questions
Questions or comments
ColdCalm.com
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073
Made in France
Otc - When Using
N/A
Otc - Do Not Use
NA
How Supplied
NA
Storage And Handling
NA
Drug Interactions
NA
* Please review the disclaimer below.