Loratadine and Pseudoephedrine
Loratadine and Pseudoephedrine is an FDA drug label for the active ingredient LORATADINE AND PSEUDOEPHEDRINE manufactured by STRATEGIC SOURCING SERVICES LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230811.
Generic: LORATADINE AND PSEUDOEPHEDRINE
Manufacturer: STRATEGIC SOURCING SERVICES LLC
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 70677-1018
Application: ANDA076557
Effective: 20230811
Active Ingredients: ACTIVE INGREDIENTS (IN EACH TABLET) Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg
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
Contraindications
Not available.
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).
Adverse Reactions
Not available.
More from same ingredient
No related products.