Organ-i Nr
FDA Label NDC 21695-048

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Organ-i Nr (NDC 21695-048). 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, use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.