Label: PSEUDOEPHEDRINE HYDROCHLORIDE tablet
- NDC Code(s): 30142-967-20
- Packager: The Kroger Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 13, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 120 mg Blister Pack Carton
COMPARE TO the active ingredient of
SUDAFED® 12 HOUR **See side panelNDC 30142-967-20
Kroger®
OUR PHARMACIST RECOMMENDED
Maximum Strength
Sinus
Pseudoephedrine Hydrochloride 120 mg
12 Hour Extended-Release Tablets, USPLONG ACTING
NASAL DECONGESTANTNON-DROWSY
Relieves Sinus
Pressure + Congestionactual
size12
HOUR20 COATED
CAPLETS*
120 mg EACH
*capsule-shaped tablets -
INGREDIENTS AND APPEARANCE
PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-967 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code 204 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-967-20 2 in 1 CARTON 02/19/2021 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 ANDA ANDA077442 02/19/2021 Labeler - The Kroger Company (006999528) Registrant - Ohm Laboratories Inc. (184769029) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(30142-967)