Label: ALLERGY NEW ENGLAND MIX- betula pubescens bark, artemisia vulgaris pollen, plantago lanceolata pollen, acer pseudoplatanus pollen, betula pubescens bark, evernia prunastri bark, armaranthus retroflexus pollen, pinus massoniana pollen, tabuliformis pollen, ambrosia artemisifolia pollen, liquid
- NDC Code(s): 43406-0106-1
- Packager: Natural Creations, Inc.
- 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 February 17, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- REFERENCES
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
-
WARNINGS
WARNINGS:
- Consult a physician for use in children under 12 years of age.
- IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
- KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
- Do not us if TAMPER EVIDENT seal is broken or missing.
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INGREDIENTS AND APPEARANCE
ALLERGY NEW ENGLAND MIX
betula pubescens bark, artemisia vulgaris pollen, plantago lanceolata pollen, acer pseudoplatanus pollen, betula pubescens bark, evernia prunastri bark, armaranthus retroflexus pollen, pinus massoniana pollen, tabuliformis pollen, ambrosia artemisifolia pollen, liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0106 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9) BETULA PUBESCENS BARK 6 [hp_X] in 1 mL ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 6 [hp_X] in 1 mL PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 6 [hp_X] in 1 mL ACER PSEUDOPLATANUS POLLEN (UNII: W8RT4P7T0H) (ACER PSEUDOPLATANUS POLLEN - UNII:W8RT4P7T0H) ACER PSEUDOPLATANUS POLLEN 6 [hp_X] in 1 mL EVERNIA PRUNASTRI (UNII: O3034Q5AHK) (EVERNIA PRUNASTRI - UNII:O3034Q5AHK) EVERNIA PRUNASTRI 6 [hp_X] in 1 mL AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 6 [hp_X] in 1 mL PINUS MASSONIANA POLLEN (UNII: D209654E9Q) (PINUS MASSONIANA POLLEN - UNII:D209654E9Q) PINUS MASSONIANA POLLEN 6 [hp_X] in 1 mL PINUS TABULIFORMIS POLLEN (UNII: 60EUO12HBX) (PINUS TABULIFORMIS POLLEN - UNII:60EUO12HBX) PINUS TABULIFORMIS POLLEN 6 [hp_X] in 1 mL AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 6 [hp_X] in 1 mL JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 6 [hp_X] in 1 mL MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 6 [hp_X] in 1 mL RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 6 [hp_X] in 1 mL POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CITRIC ACID ACETATE (UNII: DSO12WL7AU) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0106-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/29/2007 Labeler - Natural Creations, Inc. (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc. 030572478 manufacture(43406-0106)