Sinus 12 Hour Tablet, Film Coated, Extended Release
NDC Package 0113-2017-60
Package Information
Sinus 12 Hour (pseudoephedrine hcl) tablets is pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by L. Perrigo Company, this product is identified by NDC 0113-2017 and is authorized under FDA application ANDA075153.
Identification & Billing
- RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
- RxCUI: 1049154 - 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
- RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0113 - L. Perrigo Company
- 0113-2017 - Sinus 12 Hour
- 0113-2017-60 - 20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- 0113-2017 - Sinus 12 Hour
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0113-2017-60 identifies a specific commercial package of 20 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack of Sinus 12 Hour, a human over the counter drug labeled by L. Perrigo Company. This tablet, film coated, extended release is formulated for oral use and contains pseudoephedrine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by L. Perrigo Company on September 29, 2017. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). Pseudoephedrine is a decongestant (sympathomimetic). It works by narrowing the blood vessels to decrease swelling and congestion. If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Long-acting tablets/capsules are not recommended for use in children younger than 12 years. Do not use this pseudoephedrine product in children younger than 12 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
How is this L. Perrigo Company product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00113201760. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.