NDC | 64543-105-01, 64543-105-04, 64543-105-16 |
Set ID | ed6e770f-a491-4ffe-8160-24b6a5ac9c6d |
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
- Purpose
-
Usage
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis), or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- nasal congestion
- temporarily restores freer breathing through the nose
-
Warnings
Do not use
- to sedate a child or make a child sleepy
- 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 drug.
-
Ask a doctor before use if you have.
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast feeding
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
RESCON DM
chlorpheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64543-105 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64543-105-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/1999 2 NDC:64543-105-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/1999 3 NDC:64543-105-01 25 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/1999 Labeler - Capellon Pharmaceuticals, LLC (124568093) Establishment Name Address ID/FEI Business Operations Sovereign Pharmaceuticals, LLC 623168267 manufacture(64543-105)