ALLERGYCALM- onion, ambrosia artemisiifolia, euphrasia stricta, histamine dihydrochloride, schoenocaulon officinale seed, solidago virgaurea flowering top tablet

AllergyCalm by

Drug Labeling and Warnings

AllergyCalm by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Purpose*

Allium cepa 5C HPUS (0.42 mg) ... Relieves runny nose associated with allergies

Ambrosia artemisiaefolia 5C HPUS (0.42 mg) ... Relieves symptoms of 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

INDICATIONS & USAGE

Uses*

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

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

WARNINGS

ASK DOCTOR

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Adults and children 6 years of age and older - At the onset of symptoms, dissolve 2 tablets in the mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets in the mouth 3 times a day until symptoms are relieved.

Children 2 to under 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.

SPL UNCLASSIFIED SECTION

Other information

do not use if glued carton end flaps are open or if the blister seal is broken

store below 86° F (30° C)

INACTIVE INGREDIENT

croscarmellose sodium, lactose, magnesium stearate

QUESTIONS

BoironUSA.com

Info@boiron.com

1-800-BOIRON-1

(1-800-264-7661)

SPL UNCLASSIFIED SECTION

20 MELTAWAY TABLETS Unflavored

60 MELTAWAY TABLETS Unflavored

100 MELTAWAY TABLETS Unflavored

120 MELTAWAY TABLETS Unflavored

Allergy Relief*

Itchy & Watery Eyes Sneezing Itchy Throat & Nose*

Year-round Allergy Relief*

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERGYCALM 
onion, ambrosia artemisiifolia, euphrasia stricta, histamine dihydrochloride, schoenocaulon officinale seed, solidago virgaurea flowering top tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9306
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	5 [hp_C]
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	9 [hp_C]
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	5 [hp_C]
AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A)	AMBROSIA ARTEMISIIFOLIA	5 [hp_C]
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	5 [hp_C]
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	5 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	BOIRON
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9306-04	3 in 1 BOX	03/01/2022
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0220-9306-29	6 in 1 BOX	08/01/2022
2		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0220-9306-91	1 in 1 BOX	06/06/2023
3		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0220-9306-92	5 in 1 BOX	04/15/2025
4		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2022

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9306)