Label: PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated
- NDC Code(s): 70677-1019-1
- Packager: STRATEGIC SOURCING SERVICES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 11, 2023
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
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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
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton
NDC 70677-1019-1
COMPARE TO SUDAFED®
SINUS CONGESTION 12 HOUR ACTIVE INGREDIENT*Foster & Thrive™
MAXIMUM STRENGTH
Nasal Decongestant
Pseudoephedrine Hydrochloride 120 mg
Extended-Release Tablets, USP
Long-Acting Nasal DecongestantNon-Drowsy
12 hour
- Sinus Pressure + Congestion
ACTUAL SIZE
10 Coated Capsule-Shaped Tablets 120 mg Each
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INGREDIENTS AND APPEARANCE
PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1019 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 CAPSULE Size 18mm Flavor Imprint Code 204 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1019-1 1 in 1 CARTON 08/10/2023 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 08/10/2023 Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) Registrant - Ohm Laboratories Inc. (184769029) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(70677-1019)