NDC | 65193-125-48 |
Set ID | bc11389f-c988-4f67-a56e-6eaad5cb1883 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dickey Consumer Products DBA DMD |
Generic Name | |
Product Class | alpha-Adrenergic Agonist, beta-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Asthma Alert: because asthma may be life threatening, see a doctor if you: • Are not better in 60 minutes • get worse • need more than 12 tablets in 24 hours • use more than 8 tablets in 24 hours for 3 or more days a week • have more than 2 asthma attacks in a week. These may be signs that your asthma is getting worse. This product will not give you relief as quickly as an inhaled bronchodilator
Do not use: • Unless a doctor said you have asthma • 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: • ever been hospitalized for asthma • heart disease • high blood pressure • diabetes • thyroid disease • seizures • narrow angle glaucoma • a psychiatric or emotional condition • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Ask a doctor or pharmacist before use if you are: • taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions. Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)
When using this product • your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. • your risk of heart attack or stroke increases if you:• have a history of high blood pressure or heart disease • take this product more frequently or take more than the recommended dose.
• avoid foods or beverages that contain caffeine • Avoid dietary supplements containing ingredients reported or claim to have a stimulant effect.
Stop use and ask a doctor if: • your asthma is getting worse (see Asthma alert) • you have difficulty sleeping • you have a rapid heart beat • you have tremors, nervousness or seizures • cough lasts more than 1 week, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RED LABEL EPHEDRINE PLUS
ephedrine hydrochloride, guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65193-125 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE 12.5 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 (EP125) Size 9mm Flavor Imprint Code EP125 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65193-125-48 48 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/02/2019 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(65193-125) Establishment Name Address ID/FEI Business Operations Ultra Seal Corp. 085752004 pack(65193-125)