MedPath

ALLERGYCALM

AllergyCalm Pellets

Approved
Approval ID

deae124a-4db4-41fc-e053-2a95a90ac222

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

Boiron

DUNS: 282560473

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SCHOENOCAULON OFFICINALE SEED, ONION, SOLIDAGO VIRGAUREA FLOWERING TOP, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA STRICTA, HISTAMINE DIHYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code0220-9303
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 12, 2025
Generic NameSCHOENOCAULON OFFICINALE SEED, ONION, SOLIDAGO VIRGAUREA FLOWERING TOP, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA STRICTA, HISTAMINE DIHYDROCHLORIDE

INGREDIENTS (8)

SOLIDAGO VIRGAUREA FLOWERING TOPActive
Quantity: 5 [hp_C] in 1 1
Code: 5405K23S50
Classification: ACTIB
ONIONActive
Quantity: 5 [hp_C] in 1 1
Code: 492225Q21H
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
AMBROSIA ARTEMISIIFOLIAActive
Quantity: 5 [hp_C] in 1 1
Code: 9W34L2CQ9A
Classification: ACTIB
HISTAMINE DIHYDROCHLORIDEActive
Quantity: 9 [hp_C] in 1 1
Code: 3POA0Q644U
Classification: ACTIB
SCHOENOCAULON OFFICINALE SEEDActive
Quantity: 5 [hp_C] in 1 1
Code: 6NAF1689IO
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
EUPHRASIA STRICTAActive
Quantity: 5 [hp_C] in 1 1
Code: C9642I91WL
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

LABEL

LABEL

LABEL

LABEL

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

Uses*

temporarily relieves these symptoms of hay fever or upper respiratory allergies:

  • itchy and watery eyes
  • itchy throat and nose
  • sneezing
  • runny nose

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/10/2022

Active Ingredients**(in each pellet)

Allium cepa 5C HPUS (0.07 mg)

Ambrosia artemisiaefolia 5C HPUS (0.07 mg)

Euphrasia officinalis 5C HPUS (0.07 mg)

Histaminum hydrochloricum 9C HPUS (0.07 mg)

Sabadilla 5C HPUS (0.07 mg) (contains less than 10-12 mg cevadine alkaloids)

Solidago vigaurea 5C HPUS (0.07 mg)

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/10/2022

Purpose*

Relieves Allergy Symptoms: Sneezing, Runny Nose, Irritated Eyes, Itchy Throat

WARNINGS SECTION

LOINC: 34071-1Updated: 5/10/2022

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/12/2025

Ask a doctor before use if you havea breathing problem or wheezing. These could be signs of a serious condition.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/12/2025

Stop use and ask a doctor ifsymptoms persist continuously for more than 7 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/12/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/10/2022

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/12/2025
  • Adults and children 2 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved.
  • Children under 2 years of age: Ask a doctor.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/10/2022
  • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
  • contains 0.25 g of sugar per dose

Multi-Symptom Allergy Relief*

Year-Round Allergy Relief*

Non-Drowsy

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Contains approx. 80 pellets, 3.8 g (0.13 oz)

Turn tube upside down, twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

Do not use if pellet dispenser seal is broken.

*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 SECTION

LOINC: 51727-6Updated: 5/10/2022

lactose, sucrose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/10/2022

1-800-264-7661

Made in France

Distributed by

Boiron, Inc.

Newtown Square, PA 19073

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ALLERGYCALM - FDA Drug Approval Details