Label: RESCON- dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayer
- NDC Code(s): 64543-097-02, 64543-097-90
- Packager: Capellon Pharmaceuticals, LLC
- 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.
Drug Label Information
Updated November 21, 2022
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- 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)