Label: PSEUDO EPHED PLUS- pseudoephedrine hydrochloride, guaifenesin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 65193-325-24 - Packager: Dickey Consumer Products DBA DMD
- 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 March 20, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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 • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • a cough accompanied by excessive phlegm (mucus)
When using this product • do not use more than directed • intentional abuse of this product can be harmful or fatal
Stop use and ask a doctor if: • you get nervous dizzy or sleepless • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. • symptoms do not get better within 7 days or occur with a fever
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- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
PSEUDO EPHED PLUS
pseudoephedrine hydrochloride, guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65193-325 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) MALTODEXTRIN (UNII: 7CVR7L4A2D) Product Characteristics Color white (snow white) Score no score Shape ROUND (EP230) Size 9mm Flavor Imprint Code EP230 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65193-325-24 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/15/2019 Labeler - Dickey Consumer Products DBA DMD (835974056) Registrant - Dickey Consumer Products DBA DMD (835974056) Establishment Name Address ID/FEI Business Operations Ultratab Laboratories, Inc. 151051757 manufacture(65193-325) Establishment Name Address ID/FEI Business Operations Ultra Seal Corp. 085752004 pack(65193-325)
