nasal decongestant 120 mg/1
pseudoephedrine hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Meijer Distribution Inc
Pseudoephedrine hydrochloride is an oral decongestant used to temporarily relieve nasal congestion caused by colds, allergies, or sinus pressure. This extended-release tablet form is available over-the-counter to help clear nasal passages and improve breathing.
Key Facts
- Brand Name
- nasal decongestant
- Generic Name
- pseudoephedrine hydrochloride
- NDC Code (Product)
41250-809- Manufacturer
- Meijer Distribution Inc
- Strength
- 120 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075153
- Marketing Start
- 11/28/2018
Recall History
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
TG United, Inc.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
TG United, Inc.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Ultra Seal Corporation
cGMP deviations
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Ohm Laboratories, Inc.
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Dosage & Administration
Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor
Warnings
Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever 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.
Frequently Asked Questions
What is nasal decongestant used for?
Pseudoephedrine hydrochloride is an oral decongestant used to temporarily relieve nasal congestion caused by colds, allergies, or sinus pressure. This extended-release tablet form is available over-the-counter to help clear nasal passages and improve breathing.
Is nasal decongestant a controlled substance?
nasal decongestant is not classified as a controlled substance by the DEA.
What is the generic name for nasal decongestant?
The generic name for nasal decongestant is pseudoephedrine hydrochloride. There are 12 other brand versions of pseudoephedrine hydrochloride.
What is the NDC code for nasal decongestant 120 mg/1?
The NDC (National Drug Code) for nasal decongestant 120 mg/1 is 41250-809, listed by Meijer Distribution Inc.
Other Pseudoephedrine Brands
See all →- Pseudoephedrine hydrochloride120 mg/185766-050
- Sudafed Sinus Congestion 12 Hour120 mg/150090-4629
- 12 Hour Nasal Decongestant120 mg/170000-0656
- Pseudoephedrine hydrochloride120 mg/10904-7409
- Good Sense Suphedrine 12 Hour120 mg/10113-0054
- Zephrex D30 mg/10113-0401
- sinus30 mg/130142-613
- Pseudoephedrine Hydrochloride60 mg/150090-4546
- Pseudoephedrine hydrochloride120 mg/153943-204
- Pseudoephedrine Hydrochloride120 mg/159779-204
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)