1. Home
  2. Labeler Index
  3. Schwabe North America, Inc.
  4. 53499-0161
  5. Label Information: Cold Flu Relief Orange

FDA Label for Cold Flu Relief Orange

View Indications, Usage & Precautions

Table of Contents

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

Cold Flu Relief Orange Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, 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 Ingredients



Pelargonium sidoides 1X

Aconitum napellus 4X

Eucalyptus globulus 2X

Bryonia 4X

Eupatorium perfoliatum 6X

Gelsemium sempervirens 4X

Phosphorus 6X

Ipecacuanha 3X


Inactive Ingredients



Citric Acid

Lactose Monohydrate

Magnesium Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sorbitol

Stearic Acid

Xylitol


Dosage & Administration



Directions:

Chew or dissolve tablets in the mouth. Do not swallow whole.

For best results, use at 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 years of age: Take 1 chewable tablet two times daily.
Children under 6 years of age: Consult a doctor.


Indications & Usage



Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat. 


Purpose



Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat.


Warnings



Sore throat warning: if sore throat is severe, persists for 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 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 overdoese, seek medical help or contact a Poison Control Center right away. 


* Please review the disclaimer below.