Label: SUDAFED SINUS CONGESTION 24 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release
- NDC Code(s): 50580-240-01
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 20, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
- had obstruction or narrowing of the bowel. Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine).
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Directions
adults and children 12 years and over - swallow one whole tablet with water every 24 hours
- do not exceed one tablet in 24 hours
- do not divide, crush, chew or dissolve the tablet
- the tablet does not completely dissolve and may be seen in the stool (this is normal)
children under 12 years do not use this product in children under 12 years of age - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUDAFED SINUS CONGESTION 24 HOUR
pseudoephedrine hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-240 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM CHLORIDE (UNII: 451W47IQ8X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code SU;24 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-240-01 1 in 1 CARTON 06/17/2019 09/30/2025 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020021 06/17/2019 09/30/2025 Labeler - Johnson & Johnson Consumer Inc. (878046358)