Label: RED LABEL EPHED PLUS- ephedrine hydrochloride, guaifenesin tablet
- NDC Code(s): 65193-340-24, 65193-340-48
- 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.
Updated March 20, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
INGREDIENTS AND APPEARANCE
RED LABEL EPHED PLUS
ephedrine hydrochloride, guaifenesin tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65193-340 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:65193-340-24 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/20/2019 2 NDC:65193-340-48 48 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/20/2019 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(65193-340) Establishment Name Address ID/FEI Business Operations Ultra Seal Corp. 085752004 pack(65193-340)