Label: ALLERGYCALM- onion, ambrosia artemisiifolia, euphrasia stricta, histamine dihydrochloride, schoenocaulon officinale seed, solidago virgaurea flowering top tablet
- NDC Code(s): 0220-9306-04, 0220-9306-29, 0220-9306-91
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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.
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PURPOSE
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
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Adults and children 7 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 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.
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
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SPL UNCLASSIFIED SECTION
20 MELTAWAY TABLETS Unflavored
60 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
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INGREDIENTS AND APPEARANCE
ALLERGYCALM
onion, ambrosia artemisiifolia, euphrasia stricta, histamine dihydrochloride, schoenocaulon officinale seed, solidago virgaurea flowering top tabletProduct 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 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)
