Label: NASAL DECONGESTANT MAXIMUM STRENGTH- pseudoephedrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-3585-3 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 70677-0005
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 18, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- Pseudoephedrine HCl
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INGREDIENTS AND APPEARANCE
NASAL DECONGESTANT MAXIMUM STRENGTH
pseudoephedrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-3585(NDC:70677-0005) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) Product Characteristics Color RED Score no score Shape ROUND Size 7mm Flavor Imprint Code 44;112 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-3585-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/25/1981 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-3585) , REPACK(50090-3585)