![SUPRESS DX PEDIATRIC DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]](https://medic.hrt.org//dailymed/images/ddb95436-7806-4086-af4d-18a6625b5c83/SupDX1.jpg)
| NDC | 52083-055-01 |
| Set ID | ddb95436-7806-4086-af4d-18a6625b5c83 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | KRAMER NOVIS |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Drug Facts
- Active Ingredients (in each 1mL)
- Purpose
-
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)
- cough due to minor throat and bronchial irritation as may occur with the common cold
-
Warnings
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
• heart disease • thyroid disease • high blood pressure
• diabetes
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with asthmaWhen using this product do not exceed recommended dosage.
Stop use and ask a doctor if
• your child gets nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. - Directions
- Other information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
SUPRESS DX PEDIATRIC DROPS
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-055 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 1 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color red (CHERRY RED) Score Shape Size Flavor CHERRY (SOUR CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-055-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/29/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/29/2011 Labeler - KRAMER NOVIS (090158395) Registrant - KRAMER NOVIS (090158395)
