Drugplain

Loratadine and Pseudoephedrine Sulfate 10 mg/1

Loratadine and Pseudoephedrine Sulfate · TABLET, FILM COATED, EXTENDED RELEASE · Major Pharmaceuticals

2 Recalls on Record
Plain English

Loratadine and Pseudoephedrine Sulfate is a tablet, film coated, extended release containing loratadine and pseudoephedrine sulfate at 10 mg/1, taken oral. Manufactured by Major Pharmaceuticals.

Key Facts

Brand Name
Loratadine and Pseudoephedrine Sulfate
Generic Name
Loratadine and Pseudoephedrine Sulfate
NDC Code (Product)
0904-5833
Manufacturer
Major Pharmaceuticals
Strength
10 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA076557
Marketing Start
11/17/2004

Recall History

2 Recalls on Record
Class III10/12/2021

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Moisture Limits

TerminatedVoluntary: Firm initiated
Class III10/12/2021

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Moisture Limits

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective188 reports
insomnia82 reports
dizziness39 reports
off label use25 reports
headache22 reports
nausea22 reports
incorrect product administration duration18 reports
hypersensitivity17 reports
incorrect dose administered16 reports
dry mouth15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose

Dosage & Administration

Directions do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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 thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs 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 (1-800-222-1222).

Frequently Asked Questions

What is Loratadine and Pseudoephedrine Sulfate used for?

Loratadine and Pseudoephedrine Sulfate contains Loratadine and Pseudoephedrine Sulfate. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Loratadine and Pseudoephedrine Sulfate a controlled substance?

Loratadine and Pseudoephedrine Sulfate is not classified as a controlled substance by the DEA.

What is the generic name for Loratadine and Pseudoephedrine Sulfate?

The generic name for Loratadine and Pseudoephedrine Sulfate is Loratadine and Pseudoephedrine Sulfate. There are 5 other brand versions of Loratadine and Pseudoephedrine Sulfate.

What is the NDC code for Loratadine and Pseudoephedrine Sulfate 10 mg/1?

The NDC (National Drug Code) for Loratadine and Pseudoephedrine Sulfate 10 mg/1 is 0904-5833, listed by Major Pharmaceuticals.

Product NDC

0904-5833

Package NDC

0904-5833-15

Other Loratadine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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