Label: SUDOGEST- pseudoephedrine hydrochloride tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-0155-0, 50090-0155-1, 50090-0155-3, 50090-0155-4, view more50090-0155-5 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0904-5125
- 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 April 14, 2021
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 Hydrochloride
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INGREDIENTS AND APPEARANCE
SUDOGEST
pseudoephedrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0155(NDC:0904-5125) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 44;113 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-0155-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014 2 NDC:50090-0155-3 12 in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014 3 NDC:50090-0155-4 20 in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014 4 NDC:50090-0155-5 15 in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014 5 NDC:50090-0155-0 24 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 10/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/07/1984 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0155) , REPACK(50090-0155)