topcare 12 hour decongestant
topcare 12 hour decongestant is an FDA drug label for the active ingredient PSEUDOEPHEDRINE HYDROCHLORIDE manufactured by Topco Associates 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 20221005.
Generic: PSEUDOEPHEDRINE HYDROCHLORIDE
Manufacturer: Topco Associates LLC
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 36800-054
Application: ANDA075153
Effective: 20221005
Active Ingredients: Active ingredient (in each tablet) Pseudoephedrine HCl 120 mg
Indications & Usage
Uses • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure
Dosage & Administration
Directions adults and children 12 years and over • take 1 tablet every 12 hours • do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age
Contraindications
Not available.
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 • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged 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 a 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 (1-800-222-1222).
Adverse Reactions
Not available.
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