NDC | 64543-097-02, 64543-097-90 |
Set ID | 9d08d801-6cca-4a1c-ab53-5979f16e3110 |
Category | HUMAN OTC DRUG LABEL |
Packager | Capellon Pharmaceuticals, LLC |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients (per tablet)
- Purpose
- Uses
- Warnings
- When using this product
-
Do not use
- If you have a breathing problem such as emphysema or chronic bronchitis
- 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
- Stop use and ask a doctor
- Ask a doctor before use if you have
- If pregnant or breast feeding
- Keep out of the reach of children
- Directions
- Inactive ingredient
- Questions or Comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RESCON
dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayerProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64543-097 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE 2 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) D&C RED NO. 30 (UNII: 2S42T2808B) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color yellow, purple Score no score Shape OVAL Size 15mm Flavor Imprint Code RES11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64543-097-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2012 2 NDC:64543-097-02 1 in 1 POUCH; Type 0: Not a Combination Product 03/30/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/30/2012 Labeler - Capellon Pharmaceuticals, LLC (124568093)