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  5. Label Information: Organ-i Nr

FDA Label for Organ-i Nr

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. OTHER

Organ-i Nr Product Label

The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. 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



Guaifenesin, USP 200 mg


Purpose



Expectorant


Use



helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


Ask A Doctor Before Use If You Have



  • cough that occurs with too much phlegm (mucus)  
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use



Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



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.


Directions



  • do not take more than 6 doses in any 24-hour period  
  • this adult product is not intended for use in children under 12 years of age
    • adults and children
    12 years and over     		1 - 2 tablets
    every 4 hours 
    children under
    12 years     		do not use 

Other Information



  • store at 15° to 30°C (59° to 86°F)

    • You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.


Inactive Ingredients



D&C red #30 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinylpyrrolidine, pregelatinized starch, silicon dioxide, stearic acid


Other



Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 3/11 R5
8080143 4740

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320


* Please review the disclaimer below.