Label: DIABETIC TUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61787-062-04 - Packager: Health Care Products
- 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 September 13, 2010
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- Active ingredients (in each 5 mL)
- Purposes
- 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 two 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
- a cough that occurs with too much phlegm (mucus)
- a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Directions
- Other information
- Inactive ingredients
- Questions and comments?
- Package Principal Display Panel
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INGREDIENTS AND APPEARANCE
DIABETIC TUSSIN DM
dextromethorphan hydrobromide and guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-062 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CHERRY (UNII: BUC5I9595W) VANILLA (UNII: Q74T35078H) ASPARTAME (UNII: Z0H242BBR1) HYPROMELLOSE (UNII: 3NXW29V3WO) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61787-062-04 1 in 1 BOX 1 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/1997 Labeler - Health Care Products (101196749) Registrant - Hi-Tech Pharmacal Co., Inc. (101196749) Establishment Name Address ID/FEI Business Operations Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE