Outdoor Allergies Tablet
FDA Label NDC 70163-0007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Naturalcare for the product Outdoor Allergies (NDC 70163-0007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient:

(in each tablet) Adrenalinum 6X 0.006%, Aconitum Napellus 6X 0.006%, Allium Cepa 6X 0.006%, Arsenicum Iodatum 6X 0.006%, Euphrasia Officinalis 6X 0.006%, Sabadilla 6X 0.006%, Silicea 6X 0.001%, Histaminum Hydrochloricum 12X 0.006%, Ambrosia Artemisiaefolia (Ragweed) 12X 0.006%, Artemisia Vulgaris (Mugwort) 12X 0.006%, Brassica SSP. (Mustard) 12X 0.006%, Chenopodium Album (Lamb’s Quarters) 12X 0.006%, Lolium Perenne (Perennial Rye Grass) 12X 0.006%, Medicago Sativa (Alfalfa) 12X 0.006%, Phleum Pratense (Timothy Grass) 12X 0.006%, Rumex Crispus (Yellow Dock) 12X 0.006%, Taraxacum Officinale (Dandelion) 12X 0.006%, Trifolium Pratense (Red Clover) 12X 0.006%, Xanthium Strumarium (Cocklebur) 12X 0.006%.

Purpose:

Adrenalinum - decongestant, Aconitum Napellus – relieves allergy symptoms, Allium Cepa - relieves allergy symptoms, Arsenicum Iodatum - relieves allergy symptoms, Euphrasia Officinalis - relieves allergy symptoms, Sabadilla - relieves allergy symptoms, Silicea - relieves allergy symptoms, Histaminum Hydrochloricum - antihistamine, Ambrosia Artemisiaefolia (Ragweed) – assist with the management of allergy symptoms, Artemisia Vulgaris (Mugwort) - assist with the management of allergy symptoms, Brassica SSP. (Mustard) - assist with the management of allergy symptoms, Chenopodium Album (Lamb’s Quarters) - assist with the management of allergy symptoms, Lolium Perenne (Perennial Rye Grass) - assist with the management of allergy symptoms, Medicago Sativa (Alfalfa) - assist with the management of allergy symptoms, Phleum Pratense (Timothy Grass) - assist with the management of allergy symptoms, Rumex Crispus (Yellow Dock) - assist with the management of allergy symptoms, Taraxacum Officinale (Dandelion) - assist with the management of allergy symptoms, Trifolium Pratense (Red Clover) - assist with the management of allergy symptoms, Xanthium Strumarium (Cocklebur) - decongestant*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Uses:

May help temporarily relieve allergy symptoms

■ runny nose ■ congestion ■ headache ■ sore throat  ■ sneezing ■ itchy, watery eyes*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Stop use and ask a doctor if

■ symptoms do not improve in 5 days, if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting.

■ you are an asthma sufferer with severe mold allergies

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

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

Do not use if printed foil blister is broken or missing.

■ Store at room temperature (65-80°F)

Keep Out Of Reach Of Children:

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

Directions:

Adults and children 12 years and over:

■ take 2 tablets every 2 hours for 2 doses, then reduce to 1 tablet every 4 hours. For continued relief take 2 tablets 3 times daily

■ sensitive persons and asthma sufferers consult a health care practitioner

■ if allergy or asthma symptoms worsen, discontinue use

Inactive Ingredients:

croscarmellose sodium, dextrose, lactose, magnesium stearate, microcrystalline cellulose

Questions:

Dist. By NaturalCare

201 Apple Blvd.

Woodbine, IA 51579

www.NaturalCareWorks.com

1-888-280-5672

Package Label Display:

NaturalCare

bioAllers

Outdoor Allergies

Homeopathic

For Relief of*

Sneezing & Congestion

Runny Nose

Itchy, Watery Eyes

60 Tablets

* Please review the disclaimer below.