Label: PSEUDOEPHEDRINE HYDROCHLORIDE tablet
- NDC Code(s): 0904-6727-60
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
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 December 13, 2022
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- Drug Facts
- 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 INGREDIENT
- Questions or comments?
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SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 www.majorpharmaceuticals.com
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed®.
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PRINCIPAL DISPLAY PANEL
MAJOR ®
NDC 0904-6727-60
Non Drowsy SudoGest TM
Nasal Decongestant
Pseudoephedrine Hydrochloride 30mg
FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever without drowsiness
Compare to the active ingredient in Sudafed® Sinus Congestion*
100 Tablets
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INGREDIENTS AND APPEARANCE
PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6727 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 STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) KAOLIN (UNII: 24H4NWX5CO) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) SHELLAC (UNII: 46N107B71O) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color red Score no score Shape ROUND Size 6mm Flavor Imprint Code 1004 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6727-60 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/31/2019 Labeler - Major Pharmaceuticals (191427277)