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

ALLERGY NEW ENGLAND MIX by

Drug Labeling and Warnings

ALLERGY NEW ENGLAND MIX by is a Homeopathic medication manufactured, distributed, or labeled by Natural Creations, Inc., OHM Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients - equal amounts of: Birch Mix 6X, Common Mugwort 6X, English Plantain 6X, Maple Mix, Oak Mix #2 6X, Pigweed Mix 6X, Pine Mix 6X, Ragweed Mix #2 6X, Red Cedar 6X, Red Mulberry 6X, Sheep Sorrel 6X, White Popular 6X.

PURPOSE

Uses:  Temporarily relieves sneezing, watery-itchy eyes, coughing, nasal congestion, runny nose &/or other symptoms related to outdoor allergies**.

REFERENCES

** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

INDICATIONS & USAGE

Uses:  Temporarily relieves sneezing, watery-itchy eyes, coughing, nasal congestion, runny nose &/or other symptoms related to outdoor allergies.**

DOSAGE & ADMINISTRATION

Directions:  Adults & children above 12 years, spray 2 full sprays under the tongue 3 times daily, or as directed by a health care professional.

KEEP OUT OF REACH OF CHILDREN

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.

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.

INACTIVE INGREDIENT

Inactive Ingredients:  Citric Acid, Ethyl Alcohol USP, Glycerin USP, Purified Water.

QUESTIONS

NDC: 43406-0106-1

ALLERGY NEW ENGLAND MIX

HOMEOPATHIC

1 FL OZ (30mL) / 10% Alcohol

PRINCIPAL DISPLAY PANEL

NDC:  43406-0106-1

ALLERGY

NEW ENGLAND MIX

HOMEOPATHIC

1 fl oz (30 mL)/10%

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, liquid

Product 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)