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  5. Label Information: Allergy And Sinus Relief

FDA Label for Allergy And Sinus Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. PURPOSE
    4. INDICATIONS & USAGE
    5. DOSAGE & ADMINISTRATION
    6. WARNINGS
    7. ASK DOCTOR
    8. STOP USE
    9. PREGNANCY OR BREAST FEEDING
    10. KEEP OUT OF REACH OF CHILDREN
    11. OVERDOSE

Allergy And Sinus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North American, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Pelargonium sidoides 1X

Hydrastis canadensis 6X

Kali muriaticum 3X

Sanguinaria canadensis 6X

Pulsatilla 6X

Silicea 6X 


Inactive Ingredient



Citric Acid

Lactose Monohydrate

Magnesium Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sodium Croscarmellose

Sorbitol

Sour Cherry Powder

Stearic acid

Xylitol


Purpose



Temporarily relieves allergy and sinus symptoms.

Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations: cough, headache, hoarseness, sore throat, sinus pressure, chest congestion, nasal congestion, sneezing/runny nose, shrinks swollen nasal membranes, promotes sinus drainage, burning, itchy eyes, helps decongest sinus openings and passages.


Indications & Usage



Temporarily relieves allergy and sinus symptoms.

Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations: cough, headache, hoarseness, sore throat, sinus pressure, chest congestion, nasal congestion, sneezing/runny nose, shrinks swollen nasal membranes, promotes sinus drainage, burning, itchy eyes, helps decongest sinus openings and passages.


Dosage & Administration



Directions

Chew or dissolve tablets in the mouth. Do not swallow whole. For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults & Children 13 years of age and older: Take 1 chewable tablet three times daily.

Children 6-12 of age: Take 1 chewable tablet two times daily.

Children under 6 years of age: Consult a doctor.


Warnings



Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Ask Doctor



Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family


Stop Use



Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition. 


Pregnancy Or Breast Feeding



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


Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose



In case of overdose, seek medical help or contact a Poison Control center right away.


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