Active Ingredient
Guaifenesin, USP 200 mg
Organ-i Nr
FDA Label NDC 68151-1929
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Carilion Materials Management for the product Organ-i Nr (NDC 68151-1929). 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, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
How Supplied
Product: 68151-1929
NDC: 68151-1929-2 1 TABLET in a PACKAGE
* Please review the disclaimer below.
