NDC | 65193-325-24 |
Set ID | 848c680c-22c4-4b43-bc3a-21ff72e88888 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dickey Consumer Products DBA DMD |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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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)