NDC | 52083-639-16 |
Set ID | d169585f-b4f4-4831-8c71-e1533ae7e7c4 |
Category | HUMAN OTC DRUG LABEL |
Packager | Kramer Novis |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Do not use
- 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
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- 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.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - G-TUSICOF
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INGREDIENTS AND APPEARANCE
G-TUSICOF
dextromethorphan, guaifenesin, and phenylephrine syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-639 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor MINT (Mint Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-639-16 474 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/24/2012 Labeler - Kramer Novis (090158395)