The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Allergycalm (NDC 0220-9307). 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 - stop use, otc - keep out of reach of children, dosage & administration, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients** (in each tablet)
Allium cepa 5C HPUS (0.42 mg)
Ambrosia artemisiaefolia 5C HPUS (0.42 mg)
Euphrasia officinalis 5C HPUS (0.42 mg)
Histaminum hydrochloricum 9C HPUS (0.42 mg)
Sabadilla 5C HPUS (0.42 mg) (contains less than 10 -11 mg cevadine alkaloids)
Solidago vigaurea 5C HPUS (0.42 mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Allium cepa 5C HPUS (0.42 mg) ... Relieves runny nose associated with allergies
Ambrosia artemisiaefolia 5C HPUS (0.42 mg) ... Relieves spasmodic cough associated with hay fever
Euphrasia officinalis 5C HPUS (0.42 mg) ... Relieves burning, irritated eyes
Histaminum hydrochloricum 9C HPUS (0.42 mg) ... Relieves symptoms of allergic reactions
Sabadilla 5C HPUS (0.42 mg) ... Relieves sneezing and itchy throat associated with allergies
Solidago vigaurea 5C HPUS (0.42 mg) ... Relieves abundant nasal discharge
Uses*
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
itchy and water eyes
sneezing
itchy throat and nose
runny nose
spasmodic cough associated with hay fever
Warnings
Stop use and ask a doctor if
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Children 7 to 11 years of age - At the onset of symptoms, dissolve 2 tablets under the tongue every 15 minutes for 1 hour. Then take 2 tablets 3 times a day until symptoms are relieved.
Children 2 to 6 years of age - Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.
Children under 2 years of age - Ask a doctor.
Other information
60 Meltaway tablets unflavored
Allergy Relief*
Itchy & Watery Eyes Sneezing Itchy Throat & Nose*
Year-Round Allergy Relief
For Ages 2 & UP
Non-Drowsy
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
*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.
croscarmellose sodium, lactose, magnesium stearate
* Please review the disclaimer below.
